Director, AI Medical Device Programs

We are seeking a Director, AI Medical Device Programs to lead the development, regulatory execution, and post-market monitoring of Prenuvo’s AI-powered medical devices. This is a high-impact role at the intersection of R&D, regulatory science, clinical excellence, and productization.

You will oversee the end-to-end lifecycle of AI software as a medical device (SaMD)—from concept and prototyping through FDA clearance, integration into clinical workflow, and real-world performance tracking. You’ll work cross-functionally across research, regulatory, clinical, product, and engineering teams to ensure our AI innovations meet rigorous standards while continuously improving post-release.

Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise – join us to make a difference in people’s lives!

What You’ll Do

• Own the lifecycle of AI medical devices from R&D through post-market surveillance, including real-world evidence (RWE), model updates, and risk management.
• Lead regulatory strategy for AI/ML products—working closely with QA/RA to ensure compliance with FDA, CE, ISO 13485, and other global standards.
• Drive post-market monitoring programs, including performance tracking, user feedback integration, adverse event investigations, and continuous improvement cycles.
• Collaborate across AI research, clinical science, regulatory, and software engineering to define requirements, test plans, and validation strategies.
• Oversee risk management and documentation processes, including clinical evaluation, human factors, labeling, and algorithm change protocols (e.g., predetermined change control plans).
• Act as primary program lead for cross-functional coordination of AI/ML medical device development and release milestones.
• Monitor academic, technical, and regulatory trends to ensure Prenuvo stays at the forefront of AI-driven medical device innovation.

What You’ll Bring

• 5+ years of experience in SaMD and AI/ML product development, with 3+ years in a regulated healthcare or medical device setting.
• Proven track record leading cross-functional teams through the design, development, and regulatory clearance of AI-based medical products (ideally SaMD).
• Deep understanding of medical imaging, computer vision, and model validation in real-world clinical contexts.
• Strong command of relevant regulatory frameworks (e.g., FDA 510(k), SaMD guidance, ISO 13485, MDR, post-market surveillance).
• Excellent communication skills with ability to synthesize technical, clinical, and regulatory input into coherent product strategy and documentation.

Nice to Haves:

• Experience in a fast-paced, startup or growth-stage healthcare environment.
• Published work or patents in the domain of AI/ML, healthcare AI, or medical imaging.
• Familiarity with real-world data systems (e.g., PACS, EHRs) and post-market surveillance tools.
• Working knowledge of modern ML Ops and software lifecycle tools in regulated environments.

What We Offer

• An avenue to make a positive impact on people’s lives and their health
• We believe in preventative healthcare for everyone, including our team – Prenuvo provides free, whole-body scans to each team member
• Growth opportunities are at the heart of our people journey, we’re doing big things with bright minds – there is no single path to success, it can be shaped along the way
• Building strong relationships is at the core of everything we do – our team gets together each week to connect, share, and socialize
• Recognizing time away to restore is vital to our well-being – we have a flexible vacation policy and we will encourage you to use it
• We offer a comprehensive benefits package including health, dental, vision, including Mental Health coverage, to support you and your family
• The base salary for this role ranges from $195,000 $220,000 in local currency, depending upon experience

As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules.