Medical Device Quality Regulatory jobs

We are looking for a Regulatory Affairs Officer / Associate Consultant to support regulatory activities across Australia, New Zealand, and the wider JAPAC region.

The position requires strong local regulatory knowledge and must be based in Australia. The successful candidate will support clients with regulatory submissions, product registrations, lifecycle maintenance, and interactions with the TGA and Medsafe.

• Prepare and submit regulatory applications, dossiers, and compliance documentation.
• Support the registration and listing of pharmaceuticals, biologicals, and medical devices.
• Review and critically evaluate regulatory dossiers for submission to the TGA and Medsafe.
• Assist clients with responses to questions from regulatory authorities.
• Support lifecycle maintenance of existing registrations and listings.
• Prepare GMP clearance applications.
• Prepare, review, and update quality documentation.
• Support project management and client-management activities.
• Assist with the development of client proposals.
• Collaborate with other teams.

• Undergraduate qualification in pharmaceutical sciences or another relevant scientific discipline.
• Minimum of three years of experience in Australian and New Zealand regulatory affairs or quality, preferably within a commercial environment.
• Good knowledge of TGA and Medsafe legislation, regulations, guidelines, and working procedures.
• Strong written and verbal communication skills.
• Good problem-solving and project-management capabilities.
• Ability to manage confidential information.
• Strong attention to detail and ability to work to deadlines.
• Interest in consulting and continuous professional development.
• Fluent English.