Director AI Medical Device Programs
Director AI Medical Device Programs
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Job Description
About Us
At Prenuvo we are on a mission to flip the paradigm from reactive sickcare to proactive health care. Our awardwinning whole body scan is fast (under 1 hour) safe (MRI has no ionizing radiation) and noninvasive (no contrast). Our unique integrated stack of optimized hardware software and increasingly AI coupled with the patientcentric 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 and postmarket monitoring of Prenuvos AIpowered medical devices. This is a highimpact role at the intersection of R&D regulatory science clinical excellence and productization.
You will oversee the endtoend lifecycle of AI software as a medical device (SaMD)from concept and prototyping through FDA clearance integration into clinical workflow and realworld performance tracking. Youll work crossfunctionally across research regulatory clinical product and engineering teams to ensure our AI innovations meet rigorous standards while continuously improving postrelease.
Help reshape the world through proactive healthcare while working with cuttingedge technology and high performing teams with deep expertise join us to make a difference in peoples lives!
What Youll Do
- Own the lifecycle of AI medical devices from R&D through postmarket surveillance including realworld evidence (RWE) model updates and risk management.
- Lead regulatory strategy for AI/ML productsworking closely with QA/RA to ensure compliance with FDA CE ISO 13485 and other global standards.
- Drive postmarket monitoring programs including performance tracking user feedback integration adverse event investigations and continuous improvement cycles.
- Collaborate acrossAI research clinical science regulatory and software engineering to define requirements test plans and validation strategies.
- Overseerisk 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 forcrossfunctional coordination of AI/ML medical device development and release milestones.
- Monitor academic technical and regulatory trends to ensure Prenuvo stays at the forefront of AIdriven medical device innovation.
What Youll 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 crossfunctional teams through the design development and regulatory clearance of AIbased medical products (ideally SaMD).
- Deep understanding of medical imaging computer vision and model validation in realworld clinical contexts.
- Strong command of relevant regulatory frameworks (e.g. FDA 510(k) SaMD guidance ISO 13485 MDR postmarket 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 fastpaced startup or growthstage healthcare environment.
- Published work or patents in the domain of AI/ML healthcare AI or medical imaging.
- Familiarity with realworld data systems (e.g. PACS EHRs) and postmarket 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 PlatformBuilders
- Were always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of whats 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 wont stop till everyone can benefit from our work.
What We Offer
- An avenue to make a positive impact on peoples lives and their health
- We believe in preventative healthcare for everyone including our team Prenuvo provides free wholebody scans to each team member
- Growth opportunities are at the heart of our people journey were 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 wellbeing 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 $195000 $220000 in local currency depending upon experience
We are an equalopportunity 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 . If you are contacted by a recruiter please ensure their email address ends with @. We do not use thirdparty 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
Required Experience:
Director
Employment Type
Full Time
