Regulatory Affairs Lead (SaMD)

• $131000 to $157000 up to 17% Superannuation
• Fixed-term until 31 December 2026
• Heidelberg/Hybrid Location

About Us
The Australian Epilepsy Project (AEP) is a national-scale research program funded by the Medical Research Future Fund (MRFF) Frontiers Initiative and is made possible through the combined support of The Florey and other institutions. Our mission is to transform epilepsy care through world-leading diagnostics and accelerate the next wave of health innovation using big data machine learning and entrepreneurship. You can learn more about the AEP in this short video.

About The Role
We are seeking an experienced Regulatory Affairs Lead to own and lead the regulatory strategy for AEPs Software as a Medical Device (SaMD) portfolio. This is a senior hands-on role with end-to-end responsibilityfrom shaping intended use through to ARTG inclusion and postmarket compliancewhile also building fit-for-purpose quality systems in a fast-moving digital health environment.
Reporting to the Strategy and Government Affairs Lead you will work closely with executive clinical scientific commercial and technology leaders to ensure regulatory excellence enables innovation and growth.

What Youll Do

• Develop and execute regulatory strategies for SaMD products from early development to market authorisation
• Author intended use statements indications for use and device descriptions in collaboration with clinical and technical teams
• Prepare and manage ARTG submissions and lead all TGA interactions audits and correspondence
• Own device classification and risk-based regulatory decisions
• Maintain technical files design dossiers and post-market regulatory documentation
• Build and maintain an ISO 13485-compliant Quality Management System
• Lead CAPA complaint handling incident management and audit programs
• Oversee cybersecurity and data privacy compliance in regulated digital health settings
• Define regulatory pathways for future international expansion (FDA EU MDR)

About You

You are a seasoned regulatory professional with strong SaMD experience and a pragmatic mindset that understands regulation as an enabler of impact.

Youll bring

• A tertiary qualification in science medicine or a related discipline
• Strong experience leading TGA submissions and ARTG inclusions (SaMD preferred)
• Deep knowledge of Australian medical device regulations
• Working knowledge of ISO 13485 EU MDR and FDA requirements
• Experience building or scaling a QMS in a growth-stage or innovative organisation
• Understanding of cybersecurity and data privacy in digital health
• The ability to communicate regulatory risk and strategy clearly at executive level

Desirable

• Experience in neurology epilepsy digital therapeutics or clinical research
• Exposure to AI/ML regulation in medical software
• A commercial mindset aligned to patientcentred ethical research

How to Apply

If you feel this role is right for you please apply with a Cover Letter outlining your interest and experience and your Resume. Please note that you are not required to respond to the criteria in the Position Description.

Applications close Monday 18 May 2026

Visa sponsorship is not available for this position. This role requires current valid work rights for Australia. The preferred applicant for this job will be asked to consent to a police check.

Why Join Us
Be part of a purpose-driven team making a tangible impact.
Work in a collaborative environment that values innovation and inclusivity.
Collaborate with leading researchers clinicians and innovators

Working at the Florey:

The Australian Epilepsy Project is made possible through the combined support of The Florey and other institutions. With a 50-year history the Florey is the largest brain research centre in the Southern Hemisphere with teams of researchers dedicated to building knowledge on a range of neurological and psychiatric conditions. Learn more about our Research Impact.

Our reputation for innovative research and our position as the leading brain research institute in the Southern Hemisphere attracts the best and brightest. Connected by our shared mission to improve lives through brain and mental health research The Florey provides a dynamic and inspiring workplace where you can develop your career. We have a deep commitment to diversity and creating an inclusive workplace culture where our people can excel and thrive and support our exceptional people to make a positive impact on the local and global research community.

Learn more about working at the Florey here.

For enquiries please contactour People and Culture Team on.