Director, AI Medical Device Programs

About Us

At Prenuvo, we are on a mission to flip the paradigm from reactive "sick-care" to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against "we caught it too late again".

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.
  
  

Our Values

First: we are Pioneers

• Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding.
  
  

Second: we are Platform-Builders

• We're always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what's ahead – in a mindset of ownership and duty to our mission.
  
  

Above all: we are Patients

• We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients' lives, and we won't stop till everyone can benefit from our work.
  
  

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
  
  

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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

Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends with @prenuvo.com. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to [email protected].