Job Senior Regulatory Affairs Associate, Sydney

Benefits
• Work with a global leader in medical technology
• Opportunity to contribute to a high-impact product launch
• Collaborative environment with flexibility and autonomy

About the Company
Our client is a global healthcare leader renowned for developing innovative, life-changing technologies in medical devices. With a strong presence in Australia and across international markets, they are committed to improving patient care and advancing the future of healthcare.

About the Opportunity
This is an exciting opportunity to step into a Senior Regulatory Affairs Associate role, supporting a high-priority product portfolio during a critical period of growth. With a significant product launch approaching and regulatory demands increasing, this position is instrumental in ensuring efficient, compliant, and timely pre-market submissions. Reporting to a seasoned Regulatory Affairs Manager, you'll play a vital role in regulatory strategy and operations for the ANZ region.

Duties
• Manage end-to-end regulatory submissions, including TGA interactions
• Lead regulatory strategy and compile technical files, primarily adapted from EU documentation
• Prepare documentation for high-class devices: Class III IVD, Class IIb, and Class III Medical Devices
• Review local documentation and assess non-conformance where required
• Evaluate the regulatory impact of product and process changes
• Review promotional and advertising materials for compliance
• Provide regulatory support to cross-functional teams, including commercial and market access

Skills and Experience
• Tertiary qualification in a scientific or healthcare-related discipline
• Minimum 3 years of Regulatory Affairs experience in medical devices
• Strong technical writing experience, especially with regulatory files
• Experience working on TGA submissions and promotional material reviews
• Intelligent, adaptable, and a strong communicator across functions
• Self-motivated, proactive, and capable of managing priorities in a fast-paced setting

Culture
You’ll join a lean but dynamic and growing team that values innovation, autonomy, and open communication. This is a culture where big-picture thinkers who also dive deep into detail will thrive. The leadership style is supportive but hands-off, suited to someone emotionally mature and confident in self-managing their workload.

How to Apply
Ready to contribute to a high-impact medical device launch? Click apply or contact Gemma Staddon - Write to the company for a confidential discussion.

About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions across healthcare – Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care.
• Medical Affairs & Life Sciences – Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific
• Commercial – Marketing, Sales, Analytics, Government & External Affairs
• Business Operations & Infrastructure – Administration, Finance, HR, Legal, Supply Chain, IT
• Clinical Care – Allied Health, Aged Care, General Practice, Nursing, Medical Imaging