Overview
Head of Program Management – Medical Devices Jobs in San Francisco Bay Area at BioTalent
Title: Head of Program Management – Medical Devices
Company: BioTalent
Location: San Francisco Bay Area
Director of Medical Products
San Francisco, CA (Onsite)
About the Opportunity
We are building a next-generation health platform at the intersection of hardware, software, and data — with a mission to expand into the regulated medical space.
This is a 0 → 1 leadership opportunity to define, build, and scale a medical device business from the ground up. You will take an existing consumer platform and lead its transformation into a clinically validated, FDA-cleared medical product.
This role is highly cross-functional and operates at the intersection of product, regulatory, clinical, and engineering, with direct visibility to executive leadership.
What You’ll Do
- Lead the creation of a new medical product business from inception to commercialization
- Define product strategy, indications for use, and clinical positioning
- Drive FDA regulatory strategy and execution (510(k), De Novo, SaMD pathways)
- Interface directly with the FDA, including Q-Sub interactions
- Build and implement a Quality Management System (QMS) from the ground up
- Partner with external consultants across regulatory, clinical, and quality
- Own end-to-end program management across engineering, clinical, and product teams
- Rapidly prototype, test, and iterate on new medical product concepts
- Collaborate closely with executive leadership to shape long-term medical strategy
What We’re Looking For
- Experience in medical devices, digital health, or SaMD
- Proven track record of bringing a product through FDA clearance (510k, De Novo, or similar)
- Experience launching a commercially viable and/or reimbursable medical product
- Strong understanding of regulatory pathways, clinical strategy, and product development
- Demonstrated ability to operate in early-stage or startup environments
- Hands-on, execution-focused mindset — comfortable operating without established infrastructure
- Experience building or scaling QMS and regulatory processes is strongly preferred
- Excellent cross-functional leadership and program management skills
Nice to Have
- Experience with sleep-related products, respiratory devices, or wearables
- Background in Software as a Medical Device (SaMD)
- Exposure to payer strategy and reimbursement pathways
Why This Role
- True builder role — create and own a medical business from scratch
- High visibility with executive leadership and direct impact on company direction
- Opportunity to shape products that can meaningfully impact patient outcomes
- Fast-paced, high-performance environment with significant ownership
Compensation
- Base salary: $200,000 – $300,000 (flexible based on experience)
- Equity + full benefits
Work Environment
- Based in San Francisco
- Onsite 3–5 days per week
