Vice President of Regulatory Affairs and Quality Assurance

Vice President, Regulatory Affairs & Quality

San Francisco Bay Area (Hybrid)

We are partnering with a venture-backed, early-stage medical device company in the San Francisco Bay Area developing a next-generation software-driven surgical platform leveraging AI to transform procedural care.

With strong early momentum and a clear path toward clinical and regulatory milestones, the team is looking to bring on a Vice President of Regulatory Affairs & Quality to build and lead the entire RA/QA function from the ground up.

The Opportunity

This is a true foundational leadership role, reporting directly to the executive team, where you will:

• Own and define the regulatory and quality strategy for a novel AI-enabled medical device platform
• Lead FDA interactions and act as the primary point of contact with the agency
• Drive 510(k) submissions from scratch (including strategy, authoring, and execution)
• Build and scale a fit-for-purpose Quality Management System (QMS) aligned with FDA and ISO 13485
• Partner closely with R&D, Software, Clinical, and Executive leadership to align regulatory pathways with product development
• Prepare the organization for key inflection points including submissions, audits, and early commercialization

What We're Looking For

• 10–15+ years of experience in Regulatory Affairs / Quality within medical devices
• Proven track record leading 510(k) submissions from concept through clearance
• Strong experience with software-driven / SaMD / AI-enabled technologies
• Deep understanding of FDA regulations, design controls, and QMS implementation
• Prior experience in an early-stage or startup environment (highly preferred)
• Demonstrated ability to operate as a hands-on leader and strategic partner

Why This Role

• Opportunity to own and build the RA/QA function from zero
• Work directly with an experienced leadership team and investors
• Be part of a company tackling a high-impact clinical problem with differentiated technology
• Significant influence on regulatory strategy, product direction, and company trajectory