About the Company An exciting opportunity is available for an experienced Regulatory Affairs Specialist to join a growing Australian in vitro diagnostics (IVD) manufacturer with a global presence. The company develops and manufactures diagnostic products supplied internationally, with approvals across multiple regulatory jurisdictions.
About the Role This is a permanent, full-time position based in Sydney, working within a collaborative and internationally connected Regulatory Affairs team. The role will support regulatory strategy and execution across product development and lifecycle activities, with a focus on compliance with IVDR and other global regulations.
Key Responsibilities - Lead and support regulatory submissions and approvals across multiple regions (TGA, CE/IVDR, WHO)
- Prepare, review, and maintain regulatory documentation and technical files
- Manage regulatory activities for Class II and Class III medical devices
- Ensure compliance with IVDR requirements throughout the product lifecycle
- Liaise with regulatory authorities and external partners as required
- Support new product development, product changes, and post-market regulatory activities
- Work closely with R&D, Manufacturing, and Commercial teams to ensure regulatory alignment
About You This role is ideal for a regulatory professional with hands-on experience in IVD and medical devices who is ready to take ownership of IVDR compliance and international regulatory submissions.
You must have:
- 4+ years of Regulatory Affairs experience within IVD or medical devices
- Direct, practical experience with IVDR compliance (essential)
- Demonstrated experience working with Class II and Class III medical devices
- Working knowledge of global regulatory pathways, including TGA and CE marking
- Experience preparing regulatory submissions and technical documentation
- Strong written communication skills and attention to detail
- Ability to work independently and collaboratively in a fast-paced environment
Apply now to take the next step in your Regulatory Affairs career.
How to Apply
To apply, please submit your CV and a brief cover letter outlining your IVDR and Class II/III experience to KE Select via www.keselect.com. Alternatively please contact Ruby on 0481 200 171 for a confidential discussion.
KE Select is an Australian-based scientific and medical recruitment partner, specialising in permanent and temporary roles across the Life Science, Medical, Clinical, Hospital, and Healthcare sectors in Australia and New Zealand. For more information, visit www.keselect.com.
