Regulatory Affairs Associate

Regulatory Affairs Associate – Global Medical Devices (Brisbane)

Ready to step into a high‑impact RA role supporting life‑changing diagnostics and medical devices across APAC? This 12‑month contract in Brisbane gives you true regional scope, complex IVDR work and visibility with a global leader in healthcare technology.

The opportunity

Join a world‑class medical devices and diagnostics organisation whose technologies are used in over 160 countries, spanning everything from infectious disease testing to broader healthcare solutions. You will be part of the APAC Regulatory Affairs team, supporting a major IVD program that directly impacts patient access and commercial success across the region.

What you will be doing

• Support and execute regulatory submission plans designated APAC countries, in collaboration with global RA, manufacturing, supply chain and commercial teams.
• Prepare, coordinate and track product registrations and amendments, ensuring dossiers and documentation are audit‑ready and delivered to agreed timelines.
• Manage change control projects from a regional RA perspective, including risk escalation, database maintenance and KPI reporting on submission and approval status.
• Apply for and maintain Certificates of Free Sale via the TGA, including notarisation/legalisation requirements to support APAC licence renewals.
• Provide secondary support for Australian RA matters and represent APAC RA in IVDR and change control meetings as needed.

What you bring

• BSc (or equivalent) and at least 2 years’ Regulatory Affairs experience in medical devices, ideally including IVDs.
• Working knowledge of Australian medical device regulations (especially IVD), relevant standards and TGA guidance, with experience liaising with the TGA on pre‑ and post‑market topics.
• Strong project management, attention to detail and stakeholder skills, with the ability to navigate complex cross‑functional environments.
• Excellent written and verbal communication, high integrity and the capacity to manage sensitive information confidentially.

How to apply

If you are a Regulatory professional in Brisbane who enjoys complex device/IVD work and wants broader APAC exposure within a global, patient‑focused organisation, please submit your CV or reach out in confidence to discuss the role further.

Keeley Munday at kmunday@i-pharmconsulting.com