An exciting opportunity is available for an experienced Senior Regulatory Affairs Specialist to join a global medical technology organisation developing innovative solutions across orthopaedics, surgical technologies, medical devices and digital health.

Based in Frenchs 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 across Australia, 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 support FDA 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 for SaMD, 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 with FDA, Notified Bodies and the TGA and 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 experience within medical devices or a related regulated healthcare environment
- Hands-on experience with international regulatory submissions
- Strong knowledge of FDA regulations and EU MDR
- Experience with FDA 510(k) submissions
- Knowledge of ISO 13485 and ISO 14971
- TGA and Australian market-access experience would be highly regarded
- Experience with SaMD, medical device software or digital health would be a strong 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 of creative, technology-driven medical devices.

You’ll gain exposure to sophisticated surgical 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 to international 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