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 experiencedSenior Regulatory Affairs Specialistto 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 innovativemedical devices, software and AI-enabled technologiesacross 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 supportingFDA 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 withFDA, 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, includingAI and machine learningAbout YouA Bachelor's degree inScience, Biomedical Engineering, Regulatory Affairsor a related discipline5+ years' experiencewithin medical devices, healthcare or a related regulated industryExperience with regulatory submissions across theUS and European marketsStrong knowledge ofFDA regulations and EU MDRKnowledge ofISO ***** 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 withSoftware as a Medical Device (SaMD), digital health, AI or machine learning technologieswould also be a strong 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 developmentInterested?
If you're an experienced Regulatory Affairs professional looking for your next opportunity within the medical technology industry – whether you're currently based in Brisbane or willing to consider relocating – we'd love to hear from you.
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📌 Senior Regulatory Affairs Specialist (Sydney)
🏢 Lead Group
📍 Sydney