Regulatory Manager ANZ - IVD & Medical DevicesSydney, NSW | Hybrid Working AvailableKE 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 Current 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 OpportunityReporting 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 ResponsibilitiesManage regulatory affairs activities across Australia & New ZealandPrepare and maintain TGA product registrations and change notificationsSupport ARTG submissions and ongoing regulatory complianceMonitor evolving TGA,



IVDR and medical device regulationsAct as the key contact with regulatory authorities and industry bodiesSupport field corrective actions and post-market vigilance activitiesCollaborate with global regulatory and quality teamsAssist with regulatory strategy and annual regulatory planningProvide technical and strategic regulatory advice to leadership teamsSupport tender processes and commercial activities where requiredMaintain compliance with ISO***** and relevant medical device standardsContribute to future APAC regulatory initiatives as the role evolvesAbout YouTo be successful in this role you will ideally have:Bachelor's Degree in Science, Biomedical Science or related discipline3+ years experience within Regulatory Affairs in IVD, diagnostics or medical devicesStrong knowledge of TGA regulatory frameworks and ARTG submissions, exposure to equivelant regulatory frameworks in APAC preferableExperience managing regulatory processes for medical devices or diagnosticsKnowledge of ISO*****, GMP, IVDR and related quality standardsPrevious laboratory or diagnostics industry exposure highly regardedStrong stakeholder engagement and communication skillsAbility to interpret complex regulatory requirements and provide practical solutionsExperience working within global or matrix organisations advantageousWhy Apply?
Join a globally recognised diagnostics organisationStrategic leadership exposure across ANZOpportunity for future APAC involvementFlexible hybrid working arrangementsCompetitive salary package + bonus structureCollaborative and highly specialised industry environmentFor a confidential discussion regarding this opportunity, please contact:Evelyn ParkerEmail: ******: *********** ***Be careful - Don't provide your bank or credit card details when applying for jobs.
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📌 Regulatory Affairs Manager - Sydney
🏢 Select
📍 Sydney