Work with a global leader in medical technology

• Chance 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