Description:
Regulatory Affairs Associate – Medical Devices
Ready to step into a high‑impact RA role supporting life‑changing diagnostics and medical devices across APAC? This is a full-time & permanent role based in Sydney.
The opportunity
Join a world‑class medical devices and diagnostics organisation, spanning everything from infectious disease testing to broader healthcare solutions. You will 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 3 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