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 & 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 ISO***** 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 ISO*****, 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 solutionsExperience 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
Team-oriented and highly specialised industry environment
Evelyn ParkerEmail: Phone:
#J-*****-Ljbffr

📌 Regulatory Affairs Manager - Sydney (New South Wales)
🏢 KE Select Scientific & Medical Recruitment Specialists
📍 New South Wales