Senior Regulatory Affairs Specialist

Why This Role?

You'll join a growing global organisation where Regulatory Affairs has a genuine seat at the table.

Working alongside Product, Engineering, Clinical and Quality teams, you'll help shape regulatory strategy for emerging technologies including AI, machine learning and software-driven healthcare solutions.

This role offers exposure to innovative products from concept through to commercialisation, with significant visibility across international markets and senior stakeholders.

Key Responsibilities

• Develop and execute regulatory strategies for innovative medical device and digital health products.
• Lead regulatory submissions across TGA, FDA and EU MDR jurisdictions.
• Partner closely with Product Development, Engineering, Quality and Clinical teams throughout the product lifecycle.
• Provide regulatory guidance on risk management, clinical evidence, product changes and market approvals.
• Support regulatory assessments for AI-enabled and software-based healthcare technologies.
• Engage with regulators and external stakeholders across global markets.
• Monitor regulatory changes and provide strategic advice to the business.

About You

We're interested in speaking with professionals who bring:

• 5+ years' Regulatory Affairs experience within Medical Devices.
• Strong TGA regulatory experience.
• Exposure to FDA and/or EU MDR submissions and regulatory frameworks.
• Experience supporting software products, digital health platforms, AI technologies or Software as a Medical Device (SaMD).
• Strong stakeholder engagement skills and the ability to influence cross-functional teams.
• A proactive, self-driven approach with the ability to operate independently.
• Experience working across multiple international markets will be highly regarded.

Highly Regarded Experience

• AI and Machine Learning technologies.
• Digital Health platforms.
• Software product development environments.
• Medical Device classification, risk management and post-market activities.
• Collaborating with engineering and software development teams.

What's On Offer

• Join a global MedTech organisation at an exciting stage of growth.
• Work on innovative AI and software-enabled healthcare technologies.
• Significant international exposure across Australia, Europe and the United States.
• Strategic, high-impact position with strong visibility across the business.
• Work with cutting-edge technologies that are reshaping patient outcomes and healthcare delivery.
• Brisbane or Sydney location.

If you're looking for a Regulatory Affairs opportunity that offers genuine innovation, international exposure and the opportunity to influence the future of medical technology, we'd love to hear from you.