4-month contract opportunity – senior-level regulatory role with a global medical device company.

4 days on site & 1 day WFH

Job Description:

Are you a regulatory affairs professional ready to hit the ground running? This is a fantastic opportunity to step into a senior role where you’ll take ownership of end-to-end product registration activities across Australia and New Zealand.

You’ll manage regulatory submissions, liaise with TGA and Medsafe, and ensure compliance across labelling, promotional materials, and product updates. You’ll also oversee critical compliance activities such as recalls and safety alerts, working to ensure product approvals are aligned with business timelines and regulatory requirements.

Responsibilities:

Manage all aspects of product registrations across Australia and New Zealand, ensuring timely approvals in line with business objectives.

Liaise with regulatory authorities including the TGA and Medsafe to support evaluation and approval processes.

Prepare and coordinate regulatory submissions and responses to requests for further information.

Review and ensure compliance of product labelling, instructions for use, and promotional materials with applicable regulations and codes.

Analyse scientific data in registration packages to ensure readiness and compliance prior to submission.

Support regulatory compliance activities including product recalls, safety alerts, and end-of-life notifications.

Maintain up-to-date knowledge of relevant regulatory standards, guidelines, and procedures (e.g., ISO, TGA regulations).

Contribute to quality, safety, and environmental compliance by adhering to internal policies and external requirements.

Skills:

Tertiary qualification in Science or a related discipline

4–5 years’ experience in Regulatory Affairs and/or Quality within the medical device industry.

Strong working knowledge of Australian regulatory requirements, including TGA and Medsafe processes.

Demonstrated ability to work independently and manage regulatory tasks with minimal supervision.

Confident in navigating and interpreting regulatory guidelines and standards (e.g., ISO 13485, QMS).

Able to hit the ground running in a fast-paced environment, particularly within a short-term contract setting.

Apply directly now, or send your updated CV to Ben Byrne at [email protected] OR (04) 21776703