Vice President of Regulatory Affairs and Quality Assurance

Vice President, Regulatory Affairs & QualitySan 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 OpportunityThis 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 platformLead FDA interactions and act as the primary point of contact with the agencyDrive 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 13485Partner closely with R&D, Software, Clinical, and Executive leadership to align regulatory pathways with product developmentPrepare the organization for key inflection points including submissions, audits, and early commercializationWhat We’re Looking For10–15+ years of experience in Regulatory Affairs / Quality within medical devicesProven track record leading 510(k) submissions from concept through clearanceStrong experience with software-driven / SaMD / AI-enabled technologiesDeep understanding of FDA regulations, design controls, and QMS implementationPrior experience in an early-stage or startup environment (highly preferred)Demonstrated ability to operate as a hands-on leader and strategic partnerWhy This RoleOpportunity to own and build the RA/QA function from zeroWork directly with an experienced leadership team and investorsBe part of a company tackling a high-impact clinical problem with differentiated technologySignificant influence on regulatory strategy, product direction, and company trajectory