We're partnering with a global MedTech innovator that is investing heavily in next-generation healthcare technologies across Medical Devices, Digital Health, Artificial Intelligence and Software as a Medical Device (SaMD).
As part of a rapidly expanding Regulatory Affairs function, you'll play a key role in bringing innovative technologies to market across Australia, the US and Europe. This is an opportunity to move beyond purely compliance-focused regulatory work and become a trusted strategic partner influencing product development, regulatory strategy and commercial success.
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 creative 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.
Aboriginal and Torres Strait Islander Peoples are encouraged to apply.
To apply please click apply or call Christine Iannarella on +61 • •••• •235 for a confidential discussion.