Senior Regulatory Affairs Specialist - Medical DevicesBrisbane, QLD | Full-Time, Permanent$125K + Super + 5-10% BonusOpen to Candidates Willing to Consider Relocating to BrisbaneMedical Devices | Regulatory Affairs | Digital Health | Software & AIThe OpportunityAn exciting opportunity is available for an experienced Senior Regulatory Affairs Specialist to join a well-established organisation within the medical technology sector.Working as part of a global Regulatory Affairs team, you will develop and execute regulatory strategies supporting innovative medical devices, software and AI-enabled technologies across the US, European and Australian markets.This position would suit an experienced regulatory professional looking to take ownership of complex regulatory activities while working closely with Engineering, Clinical, Quality and Product Development teams throughout the product lifecycle.Candidates who are willing to consider relocating to Brisbane are encouraged to apply.The RoleAs a Senior Regulatory Affairs Specialist, your responsibilities will include:Developing and executing regulatory strategies for new and existing medical devices and softwareLeading and supporting global regulatory submissionsPreparing and supporting FDA 510(k), EU MDR and TGA submissionsWorking closely with Engineering, Clinical, Quality and Product Development teamsProviding regulatory guidance throughout the product lifecycleAdvising on risk management, clinical evidence, product testing and labellingConducting regulatory assessments for product and design changesInteracting with the FDA,



Notified Bodies and TGASupporting regulatory pre-submission meetingsSupporting post-market activities, regulatory assessments, audits and CAPAsMonitoring regulatory changes and advising stakeholders on new requirementsContributing to regulatory strategies for emerging technologies, including AI and machine learningAbout YouTo be successful, you will ideally bring:A Bachelor's degree in Science, Biomedical Engineering, Regulatory Affairs or a related discipline5+ years' experience within medical devices, healthcare or a related regulated industryExperience with regulatory submissions across the US and European marketsStrong knowledge of FDA regulations and EU MDRKnowledge of ISO ***** and ISO *****Excellent analytical and problem-solving capabilitiesStrong written and verbal communication skillsAbility to work independently while collaborating across international and cross-functional teamsTGA experience will be highly regarded.Experience with Software as a Medical Device (SaMD), digital health, AI or machine learning technologies would also be a solid advantage.What's On Offer?
$125K + Super5-10% bonusPermanent, full-time hybrid opportunityBrisbane-based positionOpen to candidates willing to consider relocating to BrisbaneExposure to international regulatory pathwaysWork across innovative medical devices, software and emerging technologiesExposure to surgical instruments and navigation systemsOpportunity to influence products from development through to market launchCollaboration with international Engineering, Clinical, Quality and Product teamsStrong opportunity for continued professional development
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📌 Senior Regulatory Affairs Specialist (Brisbane)
🏢 Lead Group
📍 Brisbane