5 Regulatory Requirements jobs in Australia

Regulatory Affairs Associate

Sydney, New South Wales Abbott

Posted 11 days ago

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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
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs Lead

St Leonards, New South Wales Stryker

Posted 8 days ago

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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.
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Senior Regulatory Affairs Specialist

Sydney, New South Wales Abbott

Posted 11 days ago

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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
This advertiser has chosen not to accept applicants from your region.

ANZ Regulatory Affairs Lead Specialist

Mascot, New South Wales GE HealthCare

Posted 11 days ago

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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
This advertiser has chosen not to accept applicants from your region.

Regulatory Lead - APAC, Kuiper Global Service Compliance External Affairs

Sydney, New South Wales Amazon

Posted 11 days ago

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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.
This advertiser has chosen not to accept applicants from your region.
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