Regulatory Manager ANZ - IVD & Medical Devices Sydney, NSW | Hybrid Working Available KE Select are proud to be partnering with a global leader within the clinical diagnostics to appoint an experienced Regulatory Manager for ANZ. This is an exciting opportunity to join a highly regarded organisation operating across molecular diagnostics, immunodiagnostics and regulated medical technologies.
This position will play a critical role in managing regulatory affairs activities across Australia and New Zealand, acting as the key liaison with the TGA and broader regulatory bodies while supporting business growth and compliance initiatives across the ANZ region.
The role also offers future APAC exposure and the opportunity to contribute strategically across a broader regional regulatory function.
The Opportunity Reporting directly to the Commercial Director, you will be responsible for driving regulatory strategy, ensuring ongoing compliance of medical device and IVD products, and supporting product registrations, submissions and post-market activities across ANZ.
You will work cross-functionally with commercial, quality and global regulatory teams while serving as the local regulatory expert for the organisation.
Key Responsibilities - Manage regulatory affairs activities across Australia & New Zealand
- Prepare and maintain TGA product registrations and change notifications
- Support ARTG submissions and ongoing regulatory compliance
- Monitor evolving TGA, IVDR and medical device regulations
- Act as the key contact with regulatory authorities and industry bodies
- Support field corrective actions and post-market vigilance activities
- Collaborate with global regulatory and quality teams
- Assist with regulatory strategy and annual regulatory planning
- Provide technical and strategic regulatory advice to leadership teams
- Support tender processes and commercial activities where required
- Maintain compliance with ISO13485 and relevant medical device standards
- Contribute to future APAC regulatory initiatives as the role evolves
About You To be successful in this role you will ideally have:
- Bachelor's Degree in Science, Biomedical Science or related discipline
- 3+ years experience within Regulatory Affairs in IVD, diagnostics or medical devices
- Strong knowledge of TGA regulatory frameworks and ARTG submissions, exposure to equivelant regulatory frameworks in APAC preferable
- Experience managing regulatory processes for medical devices or diagnostics
- Knowledge of ISO13485, GMP, IVDR and related quality standards
- Previous laboratory or diagnostics industry exposure highly regarded
- Strong stakeholder engagement and communication skills
- Ability to interpret complex regulatory requirements and provide practical solutions
- Experience working within global or matrix organisations advantageous
Why Apply? - Join a globally recognised diagnostics organisation
- Strategic leadership exposure across ANZ
- Opportunity for future APAC involvement
- Flexible hybrid working arrangements
- Competitive salary package + bonus structure
- Collaborative and highly specialised industry environment
For a confidential discussion regarding this opportunity, please contact:
Evelyn ParkerEmail: evelyn@keselect.com
Phone: +61 431 028 314
