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Quality and Regulatory Manager (AI - SaMD)Join to apply for the Quality and Regulatory Manager (AI - SaMD) role at Healthdirect AustraliaQuality and Regulatory Manager (AI - SaMD)3 weeks ago Be among the first 25 applicantsJoin to apply for the Quality and Regulatory Manager (AI - SaMD) role at Healthdirect AustraliaAbout UsAt Healthdirect Australia we work with purpose and dedication to help Australians actively manage and improve their health.About UsAt Healthdirect Australia we work with purpose and dedication to help Australians actively manage and improve their health.Our virtual services are easily accessible via multiple channels, including helplines, video call solutions and websites and cater for Australians at all stages of life. No matter where people live, or what time of the day or night it is, they can use our services to talk to a health professional, find trusted information and advice online and locate their closest health service.About The OpportunityWe''re seeking an exceptional Quality and Regulatory Manager to lead our compliance initiatives and establish a robust Quality Management System from the ground up. This critical position will ensure our adherence to TGA regulations, ISO 13485 standards, and Australian Therapeutic Goods (Medical Devices) Regulations 2002.You''ll drive continuous improvement while maintaining essential certifications and collaborate across all business units to implement efficient, effective quality processes.Key ResponsibilitiesBuild a comprehensive QMS aligned with TGA regulatory requirementsDrive quality improvement initiatives throughout the organisationSecure and maintain all necessary quality and product certificationsFacilitate cross-departmental collaboration to streamline quality processesConduct Management Review meetings and oversee regulatory reportingManage post-market surveillance activities and production correctionsProvide regular QMS performance updates to the Chief Corporate Services OfficerDeliver expert guidance on quality management across all projects and initiativesYou can contribute through your:5+ years quality management experience in software medical devicesAdvanced knowledge of ISO 13485, ISO 14971 and IEC62304 standardsProven experience implementing a QMS from ground upInternal audit and CAPA management experienceDemonstrated ability to influence stakeholders and lead changeExcellent leadership and communicationWhy work with usWe believe our strength comes from our talented and dedicated staff. We are committed to working together to create a culture where you can bring your whole self to work.Our Benefits IncludeFlexible work arrangements.14 weeks company Paid Parental Leave for both parents.Multi-dimensional wellbeing program that is run by our people for our people.Individual curated learner journeys to support you to expand your capabilities and unlock your talent.To find out more about Healthdirect, and our vision for a healthier Australia, please visit our website - about.healthdirect.gov.auAs an Equal Opportunity Employer, we respect and seek to empower each individual and support the diverse cultures, perspectives, skills, and experiences within our workforce.Click Apply to submit your application for this role. Please be aware that you must have the right to live and work in Australia to apply for this job.Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeContractJob functionJob functionQuality AssuranceIndustriesHospitals and Health CareReferrals increase your chances of interviewing at Healthdirect Australia by 2xSign in to set job alerts for Quality Regulatory Manager roles.Eveleigh, New South Wales, Australia 5 days agoMarsden Park, New South Wales, Australia 3 days agoQuality Assurance Manager - Above Water SystemsElizabeth Bay, New South Wales, Australia 14 hours agoSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 1 day agoManager, Scientific and Regulatory AffairsSydney, New South Wales, Australia 4 days agoSenior Program Manager, AU Quality Assurance (ICQA)Sydney, New South Wales, Australia 1 hour agoEveleigh, New South Wales, Australia 1 day agoSenior Regulatory Advisor - Registration (Manager, Technical & Operational Training)Sydney, New South Wales, Australia 2 days agoHead of Quality and Risk - Seniors CommunitiesSydney, New South Wales, Australia 2 weeks agoSydney, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 2 weeks agoKellyville, New South Wales, Australia 2 weeks agoCollaroy, New South Wales, Australia 3 weeks agoSydney, New South Wales, Australia 2 weeks agoQuality Assurance Lead- Adobe Experience Manager (AEM)Sydney, New South Wales, Australia 4 days agoQuality and Infection Control Coordinator, Ramsay Surgical CentresSydney, New South Wales, Australia 3 days agoGreater Sydney Area A$180,000.00-A$220,000.00 7 hours agoSydney, New South Wales, Australia 3 weeks agoMaintenance Technician (Moulding) - Night ShiftEarly Childhood Educator Casual - Certificate IIISydney, New South Wales, Australia 2 months agoEducation Coordinator, Ramsay Surgical CentresSydney, New South Wales, Australia 6 days agoWere unlocking community knowledge in a new way. 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