3 Financial Regulations jobs in Australia
Regulatory Affairs Lead
St Leonards, New South Wales
Stryker
Posted 15 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 an experienced regulatory professional with significant experience in a similar Regulatory Affairs role, ideally within the healthcare or medical devices industry (however this is not essential). You will bring a depth of knowledge and experience working within highly regulated industries, interacting with regulatory authorities and navigating complex regulatory environments. You also have strong leadership, strategic thinking, and technical expertise, with a proactive approach and a proven ability to coach teams and influence stakeholders.
**Key responsibilities**
+ **Strategic regulatory guidance:** provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals;
+ **Risk management and compliance:** identify and mitigate regulatory risks, ensuring compliance with legislation, standards and corporate procedures while supporting post-market activities and change management;
+ **Process improvement and implementation:** Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectives; and
+ **Leadership and team development:** Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team
**Must have experience/skills:**
+ A minimum of 8 years' experience within a Regulatory Affairs, Quality or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing;
+ Tertiary qualifications in a technical discipline (e.g. Science, Engineering, or related.);
+ Strong communication, negotiation and influencing skills - the ability to quickly build meaningful relationships with internal teams, external stakeholders and government departments; and
+ A self-driven, strategic thinker who can balance attention to detail and quality, with the ability to thrive in a fast-paced environment and high performance and growth organisation;
**Desired but not essential experience/skills:**
+ 5+ years of experience in Medical Device regulatory affairs, with a solid understanding of both Australian and international regulatory environments;
+ Strong knowledge of the medical device regulations in Australia and New Zealand. International regulatory knowledge also a plus! (e.g. FDA and EU MDR);
+ Experience with Prostheses List management; and
+ Team management 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 an experienced regulatory professional with significant experience in a similar Regulatory Affairs role, ideally within the healthcare or medical devices industry (however this is not essential). You will bring a depth of knowledge and experience working within highly regulated industries, interacting with regulatory authorities and navigating complex regulatory environments. You also have strong leadership, strategic thinking, and technical expertise, with a proactive approach and a proven ability to coach teams and influence stakeholders.
**Key responsibilities**
+ **Strategic regulatory guidance:** provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals;
+ **Risk management and compliance:** identify and mitigate regulatory risks, ensuring compliance with legislation, standards and corporate procedures while supporting post-market activities and change management;
+ **Process improvement and implementation:** Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency;
+ **Stakeholder engagement and issue resolution:** act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectives; and
+ **Leadership and team development:** Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team
**Must have experience/skills:**
+ A minimum of 8 years' experience within a Regulatory Affairs, Quality or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing;
+ Tertiary qualifications in a technical discipline (e.g. Science, Engineering, or related.);
+ Strong communication, negotiation and influencing skills - the ability to quickly build meaningful relationships with internal teams, external stakeholders and government departments; and
+ A self-driven, strategic thinker who can balance attention to detail and quality, with the ability to thrive in a fast-paced environment and high performance and growth organisation;
**Desired but not essential experience/skills:**
+ 5+ years of experience in Medical Device regulatory affairs, with a solid understanding of both Australian and international regulatory environments;
+ Strong knowledge of the medical device regulations in Australia and New Zealand. International regulatory knowledge also a plus! (e.g. FDA and EU MDR);
+ Experience with Prostheses List management; and
+ Team management 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.
0
Senior Regulatory Affairs Specialist
Sydney, New South Wales
Abbott
Posted 14 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.
1
Quality Assurance & Regulatory Affairs Associate
Sydney, New South Wales
GN Hearing
Posted 15 days ago
Job Viewed
Job Description
Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you!
We're on the lookout for a **Quality Assurance & Regulatory Affairs Associate** to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you'll:
+ Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
+ Support compliance with ISO13485 and local regulatory standards.
+ Act as the local Subject Matter Expert for quality processes and risk assessments.
+ Conduct internal audits and manage CAPAs, NCs, and quality records.
+ Drive validation activities for custom-manufactured products at our Sydney facility.
+ Collaborate with internal teams and corporate stakeholders across the globe.
+ Train and support teams on quality and regulatory matters.
+ Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
+ Be a key player in a high-performing, values-led QA/RA team.
We're looking for someone who:
+ Has a solid understanding of ISO 13485 and quality systems.
+ Knows their way around internal auditing, CAPA, and validation processes.
+ Is confident, detail-oriented, and self-motivated.
+ Communicates effectively with stakeholders at all levels.
+ Has 3+ years' experience in a QA/RA role, ideally in medical devices.
+ Is a natural problem-solver and thrives in a process-driven environment.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.
By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.
**The GN-owned brands that are responsible for bringing these technologies to life:**
+ Medical grade hearing technology: ReSound ( , Beltone ( , Interton ( , Jabra ( Professional collaboration: Jabra ( , BlueParrott ( , FalCom ( Gaming, calls and media: SteelSeries ( , Jabra ( in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.
If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn ( , Facebook ( and Twitter ( .
We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!
We're on the lookout for a **Quality Assurance & Regulatory Affairs Associate** to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions.
As our QA/RA Associate, you'll:
+ Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates.
+ Support compliance with ISO13485 and local regulatory standards.
+ Act as the local Subject Matter Expert for quality processes and risk assessments.
+ Conduct internal audits and manage CAPAs, NCs, and quality records.
+ Drive validation activities for custom-manufactured products at our Sydney facility.
+ Collaborate with internal teams and corporate stakeholders across the globe.
+ Train and support teams on quality and regulatory matters.
+ Represent the business in local QA/RA meetings and interactions with TGA and other bodies.
+ Be a key player in a high-performing, values-led QA/RA team.
We're looking for someone who:
+ Has a solid understanding of ISO 13485 and quality systems.
+ Knows their way around internal auditing, CAPA, and validation processes.
+ Is confident, detail-oriented, and self-motivated.
+ Communicates effectively with stakeholders at all levels.
+ Has 3+ years' experience in a QA/RA role, ideally in medical devices.
+ Is a natural problem-solver and thrives in a process-driven environment.
GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts.
GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding.
By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them.
**The GN-owned brands that are responsible for bringing these technologies to life:**
+ Medical grade hearing technology: ReSound ( , Beltone ( , Interton ( , Jabra ( Professional collaboration: Jabra ( , BlueParrott ( , FalCom ( Gaming, calls and media: SteelSeries ( , Jabra ( in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world.
If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn ( , Facebook ( and Twitter ( .
We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!
This advertiser has chosen not to accept applicants from your region.
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