An exciting opportunity is available for an experiencedSenior Regulatory Affairs Specialistto join a global medical technology organisation developing innovative solutions acrossorthopaedics, surgical technologies, medical devices and digital health.
Based inFrenchs Forest with hybrid flexibility, this position will join an established global Regulatory Affairs function and play an important role in developing and executing regulatory strategies acrossAustralia, the US and Europe.
The Role
Working closely with Engineering, Quality, Clinical and Product Development teams, you will support innovative medical technologies throughout the complete product lifecycle, from development and regulatory strategy through market approval and post-market activities.
Key responsibilities will include:
Develop and execute regulatory strategies for new and existing medical devices and software products
Lead and supportFDA 510(k), EU MDR and TGA submissions
Prepare and maintain regulatory and technical documentation
Provide regulatory guidance throughout product development and design changes
Support regulatory strategies forSaMD, digital health and AI/ML-enabled technologies
Advise teams on risk management, clinical evidence, testing and labelling requirements
Work closely with Engineering, Clinical, Quality and Product Development stakeholders
Interact withFDA, Notified Bodies and the TGAand support pre-submission activities
Support post-market regulatory assessments, audits, CAPAs and product changes
Monitor global regulatory developments and assess their impact on products and the business
To be successful,



you will ideally bring:
5+ years of Regulatory Affairs experiencewithin medical devices or a related regulated healthcare environment
Hands-on experience with international regulatory submissions
Strong knowledge ofFDA regulations and EU MDR
Experience withFDA 510(k) submissions
Knowledge ofISO ***** and ISO *****
TGA and Australian market-access experience would be highly regarded
Experience withSaMD, medical device software or digital healthwould be a robust advantage
Exposure to AI or machine-learning-enabled medical technologies would be advantageous
Degree qualification in Science, Biomedical Engineering, Regulatory Affairs or a related discipline
Strong communication skills and confidence working with international and cross-functional stakeholders
Why Consider This Opportunity?
This is an opportunity to move beyond purely maintenance-focused regulatory work and contribute to the development and commercialisation ofinnovative, technology-driven medical devices.
You'll gain exposure to sophisticatedsurgical technologies, navigation systems, software-enabled medical devices and emerging digital health solutions, while working as part of an international regulatory and product development environment.
Working arrangement:Hybrid
Industry:Medical Devices / Orthopaedics / Digital Health
If you're an experienced medical device Regulatory Affairs professional looking for greater exposure tointernational submissions, product development and emerging medical technologies, we'd be keen to hear from you.
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📌 Senior Regulatory Affairs Specialist (New South Wales)
🏢 Lead Group
📍 New South Wales