Clinical Governance & Regulatory Affairs Lead

Apply below

Melbourne or Sydney (remote/hybrid). Full-time.

NovoPsych exists to help mental health clinicians improve their client outcomes. Behind every one of the assessments we deliver is a clinician sitting with someone who is struggling, trying to understand them well enough to help. Everything we build is in service of that moment.

Since 2012, more than 75,000 mental health professionals across Australia, North America, the UK, Europe and New Zealand have used NovoPsych’s 150+ validated assessments and NovoNote, our AI scribe and clinical writing assistant. Clinicians trust us because we are scientist-led: clinical psychologists and PhD psychometricians work alongside our engineers, and we publish our research in peer-reviewed journals.

We are growing fast and are still small enough at around 30 people that every hire shapes the company. If you want your work to change how mental health care is delivered around the world, and you move quickly, this is the place.

Make sure every tool NovoPsych puts in a clinician’s hands is safe, compliant and worthy of their trust. You’ll build our clinical governance and regulatory function as regulation of AI and clinical software takes shape around the world.

The opportunity

Regulators in Australia, the US and Europe are paying close attention to AI in healthcare and to software that supports clinical decisions. We see that as an opportunity: the companies that lead on safety and evidence will earn clinicians’ trust and set the standard for the field. You’ll make NovoPsych one of them.

What you’ll do

• Build NovoPsych’s clinical governance framework: clinical risk management, incident review and safety sign-off for releases.
• Assess our products against medical device software rules in Australia (TGA), the US (FDA) and Europe, and lead any registrations or submissions.
• Track emerging AI and health regulation, and turn it into clear, practical requirements for our product and research teams.
• Work with engineers and clinicians on safety reviews of AI-generated content, such as risk statements, invented content and clinical recommendations.
• Own our evidence and claims standards, so everything we say about our tools is accurate and defensible.
• Support enterprise customers and partners with regulatory and clinical-safety documentation.
• Represent NovoPsych with regulators, professional bodies and industry groups.

You’ll thrive here if you…

• Are ambitious and want to shape how clinical AI is governed, not just follow the rules.
• See regulation as a way to build trust and a competitive edge.
• Can translate dense regulation into decisions a product team can act on this week.
• Care about patient safety and the clinicians who carry that responsibility.

Selection criteria

• 6+ years in regulatory affairs, clinical governance or quality in health technology, medical devices or digital health.
• Working knowledge of software as a medical device frameworks (TGA, FDA, EU MDR) and related standards (for example ISO 14971 risk management and ISO 13485 quality systems).
• Experience building governance or quality processes from scratch.
• Clear writing and the confidence to advise senior leaders.

Nice to have

• A background in research, such as a PhD.
• Experience with AI or machine-learning products.
• A clinical background, ideally in mental health.
• Knowledge of privacy law (Australian Privacy Act, HIPAA, GDPR).

What success looks like in 12 months

• A documented regulatory position for each product line, in Australia, the US and Europe.
• A clinical risk management process in use, with safety sign-off on every major release.
• An evidence and claims policy that marketing and product follow.
• Enterprise customers’ regulatory questions answered within days, not weeks.

What we offer

• The chance to build a clinical governance function from the ground up, at a company that takes safety seriously.
• A world-class research and clinical team. Meet the team.
• Competitive salary commensurate with experience and impact.
• Remote or hybrid flexibility, with autonomy and strong organisational support.
• Real influence over how AI in mental health is governed.

How to apply

Apply using the form below, or email your resume and cover letter to Dr Ben Buchanan. In your cover letter, please outline:

1. A governance or regulatory process you built, and what it made possible.
2. How you’d decide whether an AI clinical feature counts as a medical device, in a few sentences.
3. Key attributes or achievements that demonstrate your exceptional ability.