We’re partnering with an innovative medical device organisation that develops technology-driven healthcare solutions used across global markets. As the business continues to expand internationally, they are seeking a Senior Regulatory Affairs Specialist to lead regulatory strategy, submissions and compliance activities across their product portfolio.

This is a high-impact role where you’ll take ownership of FDA, EU MDR and international regulatory pathways, working closely with Quality, R&D; and Commercial teams to bring recent products to market and maintain global compliance. Reporting to the Head of Scientific Affairs, you’ll play a key role in supporting product development, market access and lifecycle management activities.

In this role, you will be responsible for:

- Developing regulatory strategies for new products, product changes and lifecycle activities
- Preparing and managing FDA 510(k), EU MDR, TGA, Health Canada and other global submissions
- Leading interactions with regulatory bodies, including FDA Q-Sub meetings and Notified Body communications
- Managing responses to regulatory queries and deficiency requests
- Providing regulatory guidance on marketing claims, labelling and intended use statements
- Reviewing design control, risk management and verification/validation documentation




- Supporting compliance with ISO, MDSAP and applicable global regulations
- Monitoring regulatory changes and translating them into business actions

Experience with Software as a Medical Device (SaMD) and cybersecurity requirements will be highly regarded. What you’ll bring, to be successful in this role:

- Degree-qualified in Science, Engineering or a related discipline
- 5+ years' Regulatory Affairs experience within the medical device industry
- Proven experience managing FDA 510(k) submissions
- Strong understanding of global medical device regulations, including FDA and EU MDR
- Advising on advertising and promotional claims requirements
- Excellent stakeholder management skills
- Strong analytical thinking and a practical, risk-based approach to decision-making.

This opportunity will suit a regulatory professional looking to move beyond compliance and play a strategic role in global product development and market access. You'll join a collaborative team environment and have the opportunity to influence innovative technologies that improve patient outcomes worldwide. Apply here today, or contact Sam Pickering on 0497 880 146 for a confidential discussion ASAP!

📌 Senior Regulatory Affairs Specialist - MedTech SaMD (Sydney)
🏢 Heng u0026 Hurst
📍 Sydney