Job Title

Senior Associate Global Regulatory Affairs & QualitySenior Associate Global Regulatory Affairs & QualityGet AI-powered advice on this job and more exclusive features.This range is provided by Proclinical Staffing. Your actual pay will be based on your skills and experience talk with your recruiter to learn more.Base pay rangeA$115,000.00/yr - A$125,000.00/yrDirect message the job poster from Proclinical StaffingLife Sciences Recruitment Consultant - GxP Quality Assurance & Technical at Proclinical StaffingAbout the CompanyProclinical is proud to be exclusively partnered with a growing and innovative global medical device manufacturer that is leading the way in delivering life-changing solutions for patients.This is a rare opportunity to join a purpose-driven organisation at a pivotal point in its growth journey as it transitions into a world-class, quality-led medical device company with a global footprint.About the RoleAs Senior Associate Global Regulatory Affairs & Quality, youll play a key role in post-market quality and regulatory operations, supporting compliance, continuous improvement, and robust product lifecycle management.Reporting directly to the Global Director Regulatory & Quality, you will lead complaint handling and vigilance processes, develop post-market systems, and ensure alignment with ISO 13485, TGA, and international regulatory standards.Key ResponsibilitiesManage global post-market activities including complaint handling, vigilance reporting, and coordination of investigations with offshore manufacturing.Develop and implement a centralised post-market surveillance process, including migration into a new eQMS system.Analyse and trend post-market data to support continuous improvement and risk mitigation initiatives.Liaise with internal and external stakeholders globally to ensure alignment and quality communication.Support internal and external audits, staff training, and development of controlled quality documentation.Contribute to the development and maintenance of global procedures and metrics.About YouMinimum 5 years'' experience in quality and regulatory affairs within the medical device sector.Proven experience managing post-market surveillance, complaint handling, and vigilance reporting.Strong understanding of ISO 13485, TGA, FDA, MDR and quality systems principles.Demonstrated ability to work cross-functionally across regions (e.g. Operations, R&D, Sales & Marketing).Hands-on experience with eQMS platforms highly regarded.Excellent problem-solving, communication, and data analysis skills.Degree in Life Sciences, Engineering or related discipline (equivalent experience considered).Why Apply?Be part of a purpose-driven, growing global medtech company.Work cross-functionally and make tangible impact on patient outcomes.Hybrid flexibility and strong team culture.Convenient Sydney-based head office.How to ApplyIf youre ready to take the next step in your Regulatory & Quality career, click APPLY NOW or reach out to Pamela Phoumavong, Senior Consultant at Proclinical at 02 9054 7411 or [email protected] for a confidential discussion.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionQuality AssuranceIndustriesMedical Equipment Manufacturing and Pharmaceutical ManufacturingReferrals increase your chances of interviewing at Proclinical Staffing by 2xGet notified about new Senior Quality Assurance Specialist jobs in Sydney, New South Wales, Australia.Sydney, New South Wales, Australia 3 weeks agoKogarah, New South Wales, Australia 2 weeks agoJunior Legal Assistant - Corporate CommercialSydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 2 days agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 2 days agoSydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 4 months agoSydney, New South Wales, Australia A$90,000.00-A$100,000.00 3 weeks agoLegal Assistant Dispute Resolution & LitigationSydney, New South Wales, Australia 3 weeks agoCorporate Governance and Advisory ParalegalMillers Point, New South Wales, Australia 1 week agoSydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia A$65,000.00-A$90,000.00 3 weeks agoLiverpool, New South Wales, Australia 1 day agoHurstville, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 1 day agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 3 days agoChatswood, New South Wales, Australia 3 weeks agoCorporate Associate | AM Law 50 Firm | New YorkSydney, New South Wales, Australia 2 days agoWere unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr