7 Regulatory Compliance jobs in Australia
Senior Ethics and Legal Compliance Manager - ANZ
Melbourne, Victoria
Gilead Sciences, Inc.
Posted 7 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Gilead Sciences Pty Ltd is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
We are seeking a **Senior Manager** **Compliance** to assist in enhancing and operating Gilead's healthcare compliance monitoring, risk assessment, and third-party due diligence programs for the Australia and New Zealand business (Gilead ANZ). The location of this role will be based in Melbourne, Australia.
The role reports to the Head of Legal and Compliance and is part of a Legal and Compliance team.
Gilead is currently changing the way its approach to healthcare compliance, and this role provides an opportunity to shape the future for Gilead ANZ.
**Essential Duties and Job Functions**
This individual will support the monitoring, risk assessment, and third-party due diligence teams with activities in compliance with relevant laws, the Medicines Australia Code of Conduct, and as Gilead's Healthcare Compliance Policies and Processes. These activities will include leveraging data analytics, risk-based sampling, leading risk assessment in healthcare compliance, training and discussions, and supporting any investigations and complaints.
The individual will work closely with colleagues across different functions, including key partners such as IT, Commercial, Development, Medical Affairs, Public Affairs, Government Affairs, Finance and Clinical, among others, to leverage information from relevant systems for identification and address of potential compliance-related issues.
A key goal of this position is to help drive innovation and consistency in our approach to compliance-related monitoring, risk assessment, and due diligence to ensure both Gilead and industry best practices are shared and adopted across functions.
**Key responsibilities include the following:**
+ Support the team to develop and align on a multi-faceted healthcare compliance monitoring and risk assessment strategy.
+ Drive the timely development and propagation of ongoing enhancements to the company's healthcare compliance monitoring and risk assessment program. Including
+ Collaborate with the team to ensure timely and appropriate action is taken to address potential risks and identified issues.
+ Partner with various business functions to explore ways in which monitoring and risk assessment related data may be used to support business strategy and objectives in a compliant manner.
+ Support various business functions in designing business-led monitoring approaches of both higher risk activities and third parties.
+ Responsible for review and approval of activities and engagements in defined areas of the business, including membership of the local grants committee.
+ Development and deployment of healthcare compliance training associated with Gilead's healthcare compliance policies.
+ Day to day management of compliance and governance committees.
+ Responsible for facilitating requests for diligence on new and existing vendors, including communicating with internal colleagues and third parties to gather all required information to complete diligence.
+ Conducting review of due diligence questionnaires and external checks to identify potential red flags or areas for further inquiry.
+ Serving as a resource and point-of-contact for questions from internal colleagues and third-party representatives going through due diligence.
+ Compiling and analysing reports and metrics and presenting results to colleagues, so that we can continually assess and adjust our risk-based program.
+ Manage data flow from data sources to end reporting engine for transparency reporting of transfers of value to healthcare practitioners and other key stakeholders, including taking corrective actions and remediation of data to ensure that correct, complete and accurate data flow into the Gilead's global transparency systems.
+ Foster an energizing work environment where employees have impact on our patient-centric mission and can grow their careers.
**Knowledge, Experience and Skills**
Gilead is looking for an experienced compliance professional from the biotech and/or pharmaceutical industry. Ideally the successful candidate will have gained exposure to working within a multi-national organization with a US-based headquarters and has relevant experience with the Australian healthcare compliance laws and codes. The candidate must have a strong background and exposure to healthcare compliance-related monitoring and risk assessment, compliance-related systems, with experience in change management to support effective enhancement of Gilead operations.
**Education and Skills:**
+ 7+ years of relevant prior pharmaceutical or biotechnology industry experience or other experience in highly regulated industries, including extensive professional experience advising compliance issues compliance mandates.
+ Bachelor's degree required. Advanced degree or other similar certification preferred. Legal qualifications and legal practicing certificate are not required but may be favourable.
+ Project management experience certification preferred.
+ Excellent verbal and written communication skills in English.
+ Able to exercise judgment and propose courses of action where precedent may not exist.
+ In-depth understanding of business objectives and how those translate into healthcare compliance priorities to deliver advice and guidance to the business.
+ Excellent interpersonal and influencing skills, an inquisitive mind, and the ability to work effectively in a global, matrixed organization with multiple functions, together with a positive attitude and strong work ethic.
+ Ability to present complex information in an accurate and persuasive manner to all levels of management.
+ Experience, confidence, resilience, and ability to establish rapport with key stakeholders.
+ Experience developing and using advanced Excel-based models, data analytic tools (e.g., Alteryx, Tableau) and conducting quantitative analysis including using AI tools.
+ Experience with conducting healthcare compliance monitoring, risk assessments and third-party due diligence.
+ Ability to plan monitoring activities with little to no oversight. This would include:
+ creating a project plan that clearly identifies the objective, scope, and monitoring approach;
+ generating interview guides that helps facilitate discussions to better understand the risk associated with processes; and
+ creating testing sheets that captures key controls which also aligns to the expectations of applicable policies.
+ Ability to execute a monitoring activity with little to no oversight. This would include:
+ performing data monitoring and analysing data for unusual trends, outliers, and compliance with applicable policies;
+ performing live monitoring to identify compliance issues through in-person or virtual review of an activity;
+ performing process monitoring to identify compliance issues through documentation review of an activity; and
+ sharing and validating preliminary observations with the business.
+ Ability to report on a monitoring activity with little to no oversight. This would include creating monitoring reports that clearly documents the objective, approach, observations, recommendations, and clearly present the objective, approach, and results of the monitoring report.
**Competencies and behaviours**
The ideal candidate will be solutions and results orientated. They will display personal and professional maturity and have a strong work ethic and personal integrity.
+ Proven leadership skills with an ability to set a vision, inspire, champion change, and drive innovative thinking
+ Collaborative, team player that leads by example
+ Strong strategic thinking skills with ability to see the big picture, and to formulate and execute strategy
+ Excellent influencing, interpersonal and communication skills
+ Demonstrated ability to network, engage and partner with other functions, and establish positive relationships
+ Strong judgment with proven ability to identify to implement solutions
+ Strong organizational and project management skills and ability to execute through others
+ Proven analytical skills and sound judgment
+ Practical approach to problem-solving
+ Consistently demonstrate and adhere to Gilead's Core Values and create and inspire a team culture committed to the same
**Gilead Core Values**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
Gilead Sciences Pty Ltd is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
We are seeking a **Senior Manager** **Compliance** to assist in enhancing and operating Gilead's healthcare compliance monitoring, risk assessment, and third-party due diligence programs for the Australia and New Zealand business (Gilead ANZ). The location of this role will be based in Melbourne, Australia.
The role reports to the Head of Legal and Compliance and is part of a Legal and Compliance team.
Gilead is currently changing the way its approach to healthcare compliance, and this role provides an opportunity to shape the future for Gilead ANZ.
**Essential Duties and Job Functions**
This individual will support the monitoring, risk assessment, and third-party due diligence teams with activities in compliance with relevant laws, the Medicines Australia Code of Conduct, and as Gilead's Healthcare Compliance Policies and Processes. These activities will include leveraging data analytics, risk-based sampling, leading risk assessment in healthcare compliance, training and discussions, and supporting any investigations and complaints.
The individual will work closely with colleagues across different functions, including key partners such as IT, Commercial, Development, Medical Affairs, Public Affairs, Government Affairs, Finance and Clinical, among others, to leverage information from relevant systems for identification and address of potential compliance-related issues.
A key goal of this position is to help drive innovation and consistency in our approach to compliance-related monitoring, risk assessment, and due diligence to ensure both Gilead and industry best practices are shared and adopted across functions.
**Key responsibilities include the following:**
+ Support the team to develop and align on a multi-faceted healthcare compliance monitoring and risk assessment strategy.
+ Drive the timely development and propagation of ongoing enhancements to the company's healthcare compliance monitoring and risk assessment program. Including
+ Collaborate with the team to ensure timely and appropriate action is taken to address potential risks and identified issues.
+ Partner with various business functions to explore ways in which monitoring and risk assessment related data may be used to support business strategy and objectives in a compliant manner.
+ Support various business functions in designing business-led monitoring approaches of both higher risk activities and third parties.
+ Responsible for review and approval of activities and engagements in defined areas of the business, including membership of the local grants committee.
+ Development and deployment of healthcare compliance training associated with Gilead's healthcare compliance policies.
+ Day to day management of compliance and governance committees.
+ Responsible for facilitating requests for diligence on new and existing vendors, including communicating with internal colleagues and third parties to gather all required information to complete diligence.
+ Conducting review of due diligence questionnaires and external checks to identify potential red flags or areas for further inquiry.
+ Serving as a resource and point-of-contact for questions from internal colleagues and third-party representatives going through due diligence.
+ Compiling and analysing reports and metrics and presenting results to colleagues, so that we can continually assess and adjust our risk-based program.
+ Manage data flow from data sources to end reporting engine for transparency reporting of transfers of value to healthcare practitioners and other key stakeholders, including taking corrective actions and remediation of data to ensure that correct, complete and accurate data flow into the Gilead's global transparency systems.
+ Foster an energizing work environment where employees have impact on our patient-centric mission and can grow their careers.
**Knowledge, Experience and Skills**
Gilead is looking for an experienced compliance professional from the biotech and/or pharmaceutical industry. Ideally the successful candidate will have gained exposure to working within a multi-national organization with a US-based headquarters and has relevant experience with the Australian healthcare compliance laws and codes. The candidate must have a strong background and exposure to healthcare compliance-related monitoring and risk assessment, compliance-related systems, with experience in change management to support effective enhancement of Gilead operations.
**Education and Skills:**
+ 7+ years of relevant prior pharmaceutical or biotechnology industry experience or other experience in highly regulated industries, including extensive professional experience advising compliance issues compliance mandates.
+ Bachelor's degree required. Advanced degree or other similar certification preferred. Legal qualifications and legal practicing certificate are not required but may be favourable.
+ Project management experience certification preferred.
+ Excellent verbal and written communication skills in English.
+ Able to exercise judgment and propose courses of action where precedent may not exist.
+ In-depth understanding of business objectives and how those translate into healthcare compliance priorities to deliver advice and guidance to the business.
+ Excellent interpersonal and influencing skills, an inquisitive mind, and the ability to work effectively in a global, matrixed organization with multiple functions, together with a positive attitude and strong work ethic.
+ Ability to present complex information in an accurate and persuasive manner to all levels of management.
+ Experience, confidence, resilience, and ability to establish rapport with key stakeholders.
+ Experience developing and using advanced Excel-based models, data analytic tools (e.g., Alteryx, Tableau) and conducting quantitative analysis including using AI tools.
+ Experience with conducting healthcare compliance monitoring, risk assessments and third-party due diligence.
+ Ability to plan monitoring activities with little to no oversight. This would include:
+ creating a project plan that clearly identifies the objective, scope, and monitoring approach;
+ generating interview guides that helps facilitate discussions to better understand the risk associated with processes; and
+ creating testing sheets that captures key controls which also aligns to the expectations of applicable policies.
+ Ability to execute a monitoring activity with little to no oversight. This would include:
+ performing data monitoring and analysing data for unusual trends, outliers, and compliance with applicable policies;
+ performing live monitoring to identify compliance issues through in-person or virtual review of an activity;
+ performing process monitoring to identify compliance issues through documentation review of an activity; and
+ sharing and validating preliminary observations with the business.
+ Ability to report on a monitoring activity with little to no oversight. This would include creating monitoring reports that clearly documents the objective, approach, observations, recommendations, and clearly present the objective, approach, and results of the monitoring report.
**Competencies and behaviours**
The ideal candidate will be solutions and results orientated. They will display personal and professional maturity and have a strong work ethic and personal integrity.
+ Proven leadership skills with an ability to set a vision, inspire, champion change, and drive innovative thinking
+ Collaborative, team player that leads by example
+ Strong strategic thinking skills with ability to see the big picture, and to formulate and execute strategy
+ Excellent influencing, interpersonal and communication skills
+ Demonstrated ability to network, engage and partner with other functions, and establish positive relationships
+ Strong judgment with proven ability to identify to implement solutions
+ Strong organizational and project management skills and ability to execute through others
+ Proven analytical skills and sound judgment
+ Practical approach to problem-solving
+ Consistently demonstrate and adhere to Gilead's Core Values and create and inspire a team culture committed to the same
**Gilead Core Values**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
0
Regulatory Affairs Associate
Sydney, New South Wales
Abbott
Posted 7 days ago
Job Viewed
Job Description
**About Abbott**
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.**
**An exciting 2-year fixed term contract opportunity has come up which is ideal for candidate with foundational experience in Regulatory Affairs for Medical devices/In Vitro Diagnostics. We are looking for an extremely motivated Regulatory Affairs Associate to support On-market activities. This is cross divisional role with primary functions within Diagnostics Division. This role will provide a wide range of support activities across the Regulatory Department and will be ideal for a proactive and resilient self-starter, with excellent multi-tasking abilities and a high attention to detail. Based at our head office in Macquarie Park, this role would require you to work with a close-knit team that's consistently working towards providing insights that enable smarter, faster decisions to transform the way the world is managing health.**
**The main aspects of this role include:**
**Collaborate with cross-functional teams-including marketing, sales, and logistics-to develop regulatory strategies that support on market products**
**Prepare and lodge regulatory submissions, including those requiring conformity assessments, for changes to on market in vitro diagnostic (IVD) products and updates to internal compliance records**
**Review and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding to the appropriate national authority.**
**Advise global regulatory on** **-** **market teams on local compliance needs to support innovation product maintenance requirements and/or modifications.**
**Partner with marketing to review and approve promotional content, ensuring adherence to local advertising regulations.**
**Offer mentorship, training, and support to regulatory affairs (RA) colleagues, while leveraging data to identify and implement process improvements.**
**Maintain a thorough understanding of ISO 9001, the Therapeutic Goods Act 1989, and the Australian Medical Devices Regulations 2002, along with other applicable federal and state laws.**
**Monitor and assess changes to emerging regulations for on market products and communicate potential impacts to both local and global teams.**
**Drive process updates in response to such changes, collaborating with Quality Assurance to ensure integration into the quality management system.**
**Secure additional regulatory authorisations as needed, such as import permits and Certificates of Free Sale (CFS).**
**Stay informed on global regulatory developments, guidance updates, and industry best practices.**
**Provide timely regulatory intelligence and updates to leadership and cross-functional teams.**
**Maintain regulatory documentation and records in accordance with internal procedures and regulatory requirements.**
**Ensure all regulatory decisions and activities are accurately documented.**
**Prepare regulatory reports and summaries for internal and external stakeholders.**
**Participate in cross-functional projects to meet regulatory and quality goals.**
**Promote a collaborative team culture that values open communication, diversity and shared learning.**
**What would make you a successful candidate**
**A degree in science, biomedical studies, or a related field.**
**At least 2-3 years of experience in regulatory affairs within the medical device or IVD sector.**
**Solid understanding of both Australian and international regulatory frameworks (e.g., TGA, FDA, EU IVDR).**
**Familiarity with ISO 13485 and other relevant quality standards.**
**Exceptional verbal, written, and interpersonal communication skills are essential for this role, as it requires frequent engagement with internal and external stakeholders, clear articulation of complex regulatory concepts, and the ability to build strong collaborative relationships across diverse teams.**
**Ability to work autonomously and collaboratively in a dynamic environment.**
**Exceptional attention to detail across all regulatory and quality tasks.**
**A mindset geared toward innovation and continuous improvement.**
**Proactive engagement with industry trends and regulatory updates.**
**Proven ability to manage multiple projects and competing priorities.**
**Proficiency in Microsoft Office and other standard business applications**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**Our diagnostic solutions are used in hospitals, laboratories and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.**
**An exciting 2-year fixed term contract opportunity has come up which is ideal for candidate with foundational experience in Regulatory Affairs for Medical devices/In Vitro Diagnostics. We are looking for an extremely motivated Regulatory Affairs Associate to support On-market activities. This is cross divisional role with primary functions within Diagnostics Division. This role will provide a wide range of support activities across the Regulatory Department and will be ideal for a proactive and resilient self-starter, with excellent multi-tasking abilities and a high attention to detail. Based at our head office in Macquarie Park, this role would require you to work with a close-knit team that's consistently working towards providing insights that enable smarter, faster decisions to transform the way the world is managing health.**
**The main aspects of this role include:**
**Collaborate with cross-functional teams-including marketing, sales, and logistics-to develop regulatory strategies that support on market products**
**Prepare and lodge regulatory submissions, including those requiring conformity assessments, for changes to on market in vitro diagnostic (IVD) products and updates to internal compliance records**
**Review and evaluate the scientific integrity of submission documents to ensure alignment with regulatory standards before forwarding to the appropriate national authority.**
**Advise global regulatory on** **-** **market teams on local compliance needs to support innovation product maintenance requirements and/or modifications.**
**Partner with marketing to review and approve promotional content, ensuring adherence to local advertising regulations.**
**Offer mentorship, training, and support to regulatory affairs (RA) colleagues, while leveraging data to identify and implement process improvements.**
**Maintain a thorough understanding of ISO 9001, the Therapeutic Goods Act 1989, and the Australian Medical Devices Regulations 2002, along with other applicable federal and state laws.**
**Monitor and assess changes to emerging regulations for on market products and communicate potential impacts to both local and global teams.**
**Drive process updates in response to such changes, collaborating with Quality Assurance to ensure integration into the quality management system.**
**Secure additional regulatory authorisations as needed, such as import permits and Certificates of Free Sale (CFS).**
**Stay informed on global regulatory developments, guidance updates, and industry best practices.**
**Provide timely regulatory intelligence and updates to leadership and cross-functional teams.**
**Maintain regulatory documentation and records in accordance with internal procedures and regulatory requirements.**
**Ensure all regulatory decisions and activities are accurately documented.**
**Prepare regulatory reports and summaries for internal and external stakeholders.**
**Participate in cross-functional projects to meet regulatory and quality goals.**
**Promote a collaborative team culture that values open communication, diversity and shared learning.**
**What would make you a successful candidate**
**A degree in science, biomedical studies, or a related field.**
**At least 2-3 years of experience in regulatory affairs within the medical device or IVD sector.**
**Solid understanding of both Australian and international regulatory frameworks (e.g., TGA, FDA, EU IVDR).**
**Familiarity with ISO 13485 and other relevant quality standards.**
**Exceptional verbal, written, and interpersonal communication skills are essential for this role, as it requires frequent engagement with internal and external stakeholders, clear articulation of complex regulatory concepts, and the ability to build strong collaborative relationships across diverse teams.**
**Ability to work autonomously and collaboratively in a dynamic environment.**
**Exceptional attention to detail across all regulatory and quality tasks.**
**A mindset geared toward innovation and continuous improvement.**
**Proactive engagement with industry trends and regulatory updates.**
**Proven ability to manage multiple projects and competing priorities.**
**Proficiency in Microsoft Office and other standard business applications**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
1
Regulatory Affairs Lead
St Leonards, New South Wales
Stryker
Posted 4 days ago
Job Viewed
Job Description
**About the role:**
The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.
This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.
**About you:**
You're a sharp, commercially minded professional with experience navigating complex, highly regulated environments - whether that's FMCG, Alcohol, Financial Services, Pharma, Life Sciences, or similar. You may not come from a traditional Regulatory Affairs or medical device background, and that's okay. What matters is your ability to think strategically, influence stakeholders, and solve problems with confidence and care.
You're ready to step into a role that blends compliance with commercial impact. You're a natural relationship builder, a persuasive communicator, and a curious learner who thrives in complex, fast-paced environments. You may not have led a team yet, but you're hungry to grow into leadership-and we're ready to support that journey.
**Key responsibilities**
+ **Strategic regulatory guidance:** Advise on product registration pathways, regulatory strategies, and business acquisitions to accelerate speed to market and align with commercial goals;
+ **Risk management and compliance:** Identify and mitigate regulatory risks while ensuring compliance with legislation, standards, and internal procedures. Support post-market activities and change management initiatives;
+ **Process improvement and implementation:** Lead the rollout of new regulatory processes and contribute to continuous improvement efforts that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** Act as a trusted escalation point for complex regulatory issues. Collaborate cross-functionally to resolve challenges and deliver strategic solutions **;** and
+ **Leadership and team development:** Coach and support peers and junior team members, building technical capability and fostering a culture of growth and learning.
**Must have experience/skills:**
We're looking for someone with a unique blend of skills and mindset. You'll thrive here if you have:
+ Exposure to highly regulated industries and a strong understanding of compliance frameworks;
+ Tertiary qualifications in a related discipline;
+ Excellent communication, negotiation, and influencing skills;
+ A strategic mindset with the ability to balance detail and big-picture thinking;
+ A collaborative style and the ability to navigate competing priorities;
+ A passion for continuous improvement and smarter ways of working; and
+ An interest in coaching, mentoring and developing teams with a desire to grow into leadership in future.
**Desired but not essential experience/skills:**
If you've got any of the following, that's a plus-but not a dealbreaker:
+ Experience in medical device regulatory affairs (Australia, NZ, FDA, EU MDR);
+ Familiarity with Prostheses List management; and
+ Prior team management or mentoring experience.
**To join us, click apply now!**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
The Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.
This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation for complex regulatory matters. Additionally, the Regulatory Affairs Lead will coach and mentor team members, providing guidance to support their professional development.
**About you:**
You're a sharp, commercially minded professional with experience navigating complex, highly regulated environments - whether that's FMCG, Alcohol, Financial Services, Pharma, Life Sciences, or similar. You may not come from a traditional Regulatory Affairs or medical device background, and that's okay. What matters is your ability to think strategically, influence stakeholders, and solve problems with confidence and care.
You're ready to step into a role that blends compliance with commercial impact. You're a natural relationship builder, a persuasive communicator, and a curious learner who thrives in complex, fast-paced environments. You may not have led a team yet, but you're hungry to grow into leadership-and we're ready to support that journey.
**Key responsibilities**
+ **Strategic regulatory guidance:** Advise on product registration pathways, regulatory strategies, and business acquisitions to accelerate speed to market and align with commercial goals;
+ **Risk management and compliance:** Identify and mitigate regulatory risks while ensuring compliance with legislation, standards, and internal procedures. Support post-market activities and change management initiatives;
+ **Process improvement and implementation:** Lead the rollout of new regulatory processes and contribute to continuous improvement efforts that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** Act as a trusted escalation point for complex regulatory issues. Collaborate cross-functionally to resolve challenges and deliver strategic solutions **;** and
+ **Leadership and team development:** Coach and support peers and junior team members, building technical capability and fostering a culture of growth and learning.
**Must have experience/skills:**
We're looking for someone with a unique blend of skills and mindset. You'll thrive here if you have:
+ Exposure to highly regulated industries and a strong understanding of compliance frameworks;
+ Tertiary qualifications in a related discipline;
+ Excellent communication, negotiation, and influencing skills;
+ A strategic mindset with the ability to balance detail and big-picture thinking;
+ A collaborative style and the ability to navigate competing priorities;
+ A passion for continuous improvement and smarter ways of working; and
+ An interest in coaching, mentoring and developing teams with a desire to grow into leadership in future.
**Desired but not essential experience/skills:**
If you've got any of the following, that's a plus-but not a dealbreaker:
+ Experience in medical device regulatory affairs (Australia, NZ, FDA, EU MDR);
+ Familiarity with Prostheses List management; and
+ Prior team management or mentoring experience.
**To join us, click apply now!**
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
This advertiser has chosen not to accept applicants from your region.
2
Senior Regulatory Affairs Specialist
Macquarie Park, New South Wales
Medtronic
Posted 27 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value - and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic!
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
The Senior Regulatory Affairs Specialist (RAS) - INTERNATIONAL will help in planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within Asia Pacific markets. This position ensures compliance with required global regulations and Medtronic policies for Diabetes products and serves as a key team member and/or in a lead role on extended team(s).
**Responsibilities may include the following and other duties may be assigned:**
+ Partner with local country RA affiliates to help planning, developing, and executing global regulatory activities necessary to obtain and maintain regulatory approvals in APAC region.
+ Interact with local RA team within APAC region and provide support needed.
+ Support and strengthen communication process between international RA and operating unit RA team.
+ Supports local RA team to prepare local submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.
+ Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.
+ Participate and represent OUS regulatory function in sustaining (Including MDR) and new product development projects to provide OUS regulatory requirements.
+ Assist in keeping company informed of regulatory requirements in APAC region.
+ Supports product demand planning and release activities.
+ ·Follow all assigned standard operating procedures and company policies to ensure compliance.
+ Supports all post markets regulatory requirements and audit requests.
+ Partner with local affiliates to help planning and executing license transfer and rebranding duties for the region.
+ Other duties as assigned or required.
**Required Knowledge and Experience:**
+ Bachelor's degree required with a minimum of 3-5 years of medical device regulatory affairs experience.
+ Medical Device regulatory submission/approval experience.
+ Knowledge of Asia Pacific regulations/requirements (eg TGA, PMDN, MFDS, TFDA.etc).
+ Strong Interpersonal and analytical skills.
+ Strong communication and technical writing skills.
+ Attention to detail.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
Medtronic is a market leader, and our expanding portfolio delivers measurable clinical and economic value - and opens doors. With a passion for helping patients and a commercial mindset, you will make a significant difference together with Medtronic!
Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.
The Senior Regulatory Affairs Specialist (RAS) - INTERNATIONAL will help in planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within Asia Pacific markets. This position ensures compliance with required global regulations and Medtronic policies for Diabetes products and serves as a key team member and/or in a lead role on extended team(s).
**Responsibilities may include the following and other duties may be assigned:**
+ Partner with local country RA affiliates to help planning, developing, and executing global regulatory activities necessary to obtain and maintain regulatory approvals in APAC region.
+ Interact with local RA team within APAC region and provide support needed.
+ Support and strengthen communication process between international RA and operating unit RA team.
+ Supports local RA team to prepare local submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements.
+ Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures.
+ Participate and represent OUS regulatory function in sustaining (Including MDR) and new product development projects to provide OUS regulatory requirements.
+ Assist in keeping company informed of regulatory requirements in APAC region.
+ Supports product demand planning and release activities.
+ ·Follow all assigned standard operating procedures and company policies to ensure compliance.
+ Supports all post markets regulatory requirements and audit requests.
+ Partner with local affiliates to help planning and executing license transfer and rebranding duties for the region.
+ Other duties as assigned or required.
**Required Knowledge and Experience:**
+ Bachelor's degree required with a minimum of 3-5 years of medical device regulatory affairs experience.
+ Medical Device regulatory submission/approval experience.
+ Knowledge of Asia Pacific regulations/requirements (eg TGA, PMDN, MFDS, TFDA.etc).
+ Strong Interpersonal and analytical skills.
+ Strong communication and technical writing skills.
+ Attention to detail.
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
3
Senior Regulatory Affairs Specialist
Sydney, New South Wales
Abbott
Posted 7 days ago
Job Viewed
Job Description
**About Abbott**
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**Amazing health and wellness benefits and perks.**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.**
**Overview**
**This role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.**
**Responsibilities**
**Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.**
**Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.**
**Provide assessment on product and manufacturing changes in relation to regulatory actions.**
**Review and approving promotional material for compliance with relevant regulations and codes.**
**Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders**
**Provide training and guidance on Regulatory topics to stakeholders where applicable.**
**Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.**
**You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.**
**Qualifications and Experience**
**Essential**
**Science Degree or equivalent**
**Minimum 7 years Regulatory experience within the medical devices or IVD industry.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.**
**Working at Abbott**
**At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:**
**Career development with an international company where you can grow the career you dream of .**
**Amazing health and wellness benefits and perks.**
**A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.**
**A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.**
**We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.**
**Overview**
**This role is responsible for the primary responsibility of regulatory activities in Australia and New Zealand. Including managing the regulatory submissions and product updates, approving advertising materials and being responsible for regulatory and legislation changes.**
**Responsibilities**
**Manage all aspects of product registration with regulatory authorities in Australia and New Zealand to ensure regulatory approvals are achieved in accordance with Company objectives. Monitor progress of applications through the regulatory system.**
**Be the main contact for TGA and Medsafe to facilitate evaluation and other regulatory processes.**
**Provide assessment on product and manufacturing changes in relation to regulatory actions.**
**Review and approving promotional material for compliance with relevant regulations and codes.**
**Be the SME of all Australian and New Zeal and Therapeutic Goods regulations and providing guidance and strategy for Affiliate and Global stakeholders**
**Provide training and guidance on Regulatory topics to stakeholders where applicable.**
**Maintain good working knowledge of relevant Federal and State Regulations and standard guidelines and procedures.**
**You may be required to work outside of your ordinary hours of work to participate in essential training, team meetings, customer events or trade shows/conferences. These events may take place on an evening and/or weekend.**
**Qualifications and Experience**
**Essential**
**Science Degree or equivalent**
**Minimum 7 years Regulatory experience within the medical devices or IVD industry.**
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
This advertiser has chosen not to accept applicants from your region.
4
ANZ Regulatory Affairs Lead Specialist
Mascot, New South Wales
GE HealthCare
Posted 7 days ago
Job Viewed
Job Description
**Job Description Summary**
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, pre-market submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
This position is a 12 month maternity leave contract.
**Job Description**
**Roles and Responsibilities**
+ Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
+ Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
+ Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
+ Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
+ Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
**Required Qualifications**
+ This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
**Desired Characteristics**
+ Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
**Additional Information**
**Relocation Assistance Provided:** No
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, pre-market submissions/registrations and post-market compliance, working closely with healthcare regulatory bodies globally. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market.
This position is a 12 month maternity leave contract.
**Job Description**
**Roles and Responsibilities**
+ Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
+ Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
+ Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
+ Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
+ Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
**Required Qualifications**
+ This role requires advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
**Desired Characteristics**
+ Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
**Additional Information**
**Relocation Assistance Provided:** No
This advertiser has chosen not to accept applicants from your region.
5
Regulatory Lead - APAC, Kuiper Global Service Compliance External Affairs
Sydney, New South Wales
Amazon
Posted 7 days ago
Job Viewed
Job Description
Description
Project Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of customers, including consumers, businesses, government agencies, and other organizations operating in places without reliable connectivity.
The Regulatory Communications Specialist - APAC will be the external point of contact for Project Kuiper's service compliance obligation deliverables in front of Asia Pacific telecommunications regulators. This role will use their specific knowledge of communications regulation to advance Kuiper's policy interests by coordinating complex compliance filings, maintaining effective lines-of-communication with relevant regulatory bodies and developing mechanisms to ensure scalability.
This position may require access to information, technology, or hardware that is subject to export control laws and regulations, including the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR). Employment in this position is contingent upon obtaining any required export licenses or other approvals from the United States government. As such, the successful candidate must be eligible to obtain any necessary export licenses or approvals based on their nationality, citizenship, and any other factors considered by the applicable export control regulations.
Key job responsibilities
* Interface directly with APAC Regulators to drive Kuiper Compliance strategy and perform advocacy consistent with Kuiper's policy priorities
* Develop and optimize mechanisms to ensure accurate and timely filing of complex communications service provider compliance filings
* Align with Compliance, Legal, Regulatory, Public Policy and Global Expansions on strategy for Communications Service Provider compliance matters
* Drive timely and accurate compliance filings related to the regulatory obligations that arise as a result of Project Kuiper's status as a communications service provider (e.g., revenue reporting, subscribership reports, outage reporting, customer complaints)
* Coordinate across Kuiper entities, and across Amazon addressing the unique nature of Kuiper operating as a global Communications Service Provider
Basic Qualifications
* Experience performing regulatory advocacy to support complex compliance requirements
* Experience supporting the Telecommunications/Satellite industry or other highly regulated industries on compliance matters
Preferred Qualifications
* Direct knowledge of APAC communications regulatory frameworks highly preferred
* Excellent ability to build strong relationships with internal and external clients
* Experience working directly with regulators on communications compliance obligations
* Experience translating complex compliance requirements into operational processes
* Second APAC language skills highly preferred
Acknowledgement of country:
In the spirit of reconciliation Amazon acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.
IDE statement:
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.
Project Kuiper is an initiative to increase global broadband access through a constellation of 3,236 satellites in low Earth orbit (LEO). Its mission is to bring fast, affordable broadband to unserved and underserved communities around the world. Project Kuiper will help close the digital divide by delivering fast, affordable broadband to a wide range of customers, including consumers, businesses, government agencies, and other organizations operating in places without reliable connectivity.
The Regulatory Communications Specialist - APAC will be the external point of contact for Project Kuiper's service compliance obligation deliverables in front of Asia Pacific telecommunications regulators. This role will use their specific knowledge of communications regulation to advance Kuiper's policy interests by coordinating complex compliance filings, maintaining effective lines-of-communication with relevant regulatory bodies and developing mechanisms to ensure scalability.
This position may require access to information, technology, or hardware that is subject to export control laws and regulations, including the Export Administration Regulations (EAR) and the International Traffic in Arms Regulations (ITAR). Employment in this position is contingent upon obtaining any required export licenses or other approvals from the United States government. As such, the successful candidate must be eligible to obtain any necessary export licenses or approvals based on their nationality, citizenship, and any other factors considered by the applicable export control regulations.
Key job responsibilities
* Interface directly with APAC Regulators to drive Kuiper Compliance strategy and perform advocacy consistent with Kuiper's policy priorities
* Develop and optimize mechanisms to ensure accurate and timely filing of complex communications service provider compliance filings
* Align with Compliance, Legal, Regulatory, Public Policy and Global Expansions on strategy for Communications Service Provider compliance matters
* Drive timely and accurate compliance filings related to the regulatory obligations that arise as a result of Project Kuiper's status as a communications service provider (e.g., revenue reporting, subscribership reports, outage reporting, customer complaints)
* Coordinate across Kuiper entities, and across Amazon addressing the unique nature of Kuiper operating as a global Communications Service Provider
Basic Qualifications
* Experience performing regulatory advocacy to support complex compliance requirements
* Experience supporting the Telecommunications/Satellite industry or other highly regulated industries on compliance matters
Preferred Qualifications
* Direct knowledge of APAC communications regulatory frameworks highly preferred
* Excellent ability to build strong relationships with internal and external clients
* Experience working directly with regulators on communications compliance obligations
* Experience translating complex compliance requirements into operational processes
* Second APAC language skills highly preferred
Acknowledgement of country:
In the spirit of reconciliation Amazon acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today.
IDE statement:
Amazon is an equal opportunity employer and does not discriminate on the basis of protected veteran status, disability, or other legally protected status.
Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit for more information. If the country/region you're applying in isn't listed, please contact your Recruiting Partner.
This advertiser has chosen not to accept applicants from your region.
Be The First To Know
About the latest Regulatory compliance Jobs in Australia !
6