Job Title

2 days ago Be among the first 25 applicantsDirect message the job poster from Healthcare Professionals GroupDivisional Manager @HPG - Recruiting, Medical Affairs, Regulatory Affairs, Health Economics & Market Access professionals into the Pharma, Biotech &...Benefits Work with a global leader in medical technology Opportunity to contribute to a high-impact product launch Collaborative environment with flexibility and autonomyAbout the CompanyOur client is a global healthcare leader renowned for developing innovative, life-changing technologies in medical devices. With a strong presence in Australia and across international markets, they are committed to improving patient care and advancing the future of healthcare.About the OpportunityThis is an exciting opportunity to step into a Senior Regulatory Affairs Associate role, supporting a high-priority product portfolio during a critical period of growth. With a significant product launch approaching and regulatory demands increasing, this position is instrumental in ensuring efficient, compliant, and timely pre-market submissions. Reporting to a seasoned Regulatory Affairs Manager, you''ll play a vital role in regulatory strategy and operations for the ANZ region.Duties Manage end-to-end regulatory submissions, including TGA interactions Lead regulatory strategy and compile technical files, primarily adapted from EU documentation Prepare documentation for high-class devices: Class III IVD, Class IIb, and Class III Medical Devices Review local documentation and assess non-conformance where required Evaluate the regulatory impact of product and process changes Review promotional and advertising materials for compliance Provide regulatory support to cross-functional teams, including commercial and market accessSkills and Experience Tertiary qualification in a scientific or healthcare-related discipline Minimum 3 years of Regulatory Affairs experience in medical devices Strong technical writing experience, especially with regulatory files Experience working on TGA submissions and promotional material reviews Intelligent, adaptable, and a strong communicator across functions Self-motivated, proactive, and capable of managing priorities in a fast-paced settingCultureYou''ll join a lean but dynamic and growing team that values innovation, autonomy, and open communication. This is a culture where big-picture thinkers who also dive deep into detail will thrive. The leadership style is supportive but hands-off, suited to someone emotionally mature and confident in self-managing their workload.How to ApplyReady to contribute to a high-impact medical device launch? Click apply or contact Gemma Staddon - gstaddon@hpgconnectfor a confidential discussion.About Healthcare Professionals GroupHealthcare Professionals Group recruits all positions across healthcare Pharmaceuticals, Biotechnology, Medical Technology, and Clinical Care. Medical Affairs & Life Sciences Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific Commercial Marketing, Sales, Analytics, Government & External Affairs Business Operations & Infrastructure Administration, Finance, HR, Legal, Supply Chain, IT Clinical Care Allied Health, Aged Care, General Practice, Nursing, Medical ImagingSeniority levelSeniority levelNot ApplicableEmployment typeEmployment typeContractJob functionJob functionScienceIndustriesMedical Equipment ManufacturingReferrals increase your chances of interviewing at Healthcare Professionals Group by 2xSign in to set job alerts for "Senior Regulatory Affairs Associate" roles.Sydney, New South Wales, Australia 1 month agoSydney, New South Wales, Australia 4 days agoSydney, New South Wales, Australia A$75.00-A$77.00 1 day agoSydney, New South Wales, Australia 3 weeks agoManager Regulatory Affairs and EngagementSydney, New South Wales, Australia 4 days agoSenior Manager Regulatory Affairs and EngagementSydney, New South Wales, Australia 4 days agoRegulatory Affairs Manager | Rare Disease | SYDSydney, New South Wales, Australia 1 day agoRegulatory Affairs Post-Market ConsultantSydney, New South Wales, Australia 4 weeks agoRegulatory Risk Senior Consultant/ManagerSydney, New South Wales, Australia 3 weeks agoAshurst Reach Legal Consultant Regulatory law - SydneySydney, New South Wales, Australia 2 weeks agoChatswood, New South Wales, Australia 5 days agoSydney, New South Wales, Australia A$120,000.00-A$130,000.00 3 weeks agoNorth Ryde, New South Wales, Australia 2 days agoSenior Associate Global Regulatory Affairs & QualitySydney, New South Wales, Australia A$115,000.00-A$125,000.00 5 hours agoRegulatory Affairs Specialist | Medical Devices | NSWSydney, New South Wales, Australia 3 weeks agoQuality Assurance & Regulatory Affairs AssociateSydney, New South Wales, Australia 2 weeks agoWe''re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr