Vice President Regulatory Affairs

Vice President, Regulatory AffairsUSA (Remote)$300,000 - $350,000 + Bonus + Equity Job DescriptionEPM is partnered with a pioneering medical device company developing first-in-class technologies aimed at addressing critical unmet clinical needs in high-acuity therapeutic areas. With a robust pipeline spanning early feasibility through commercialization, including multiple Class III programs, the organization is seeking a Vice President of Regulatory Affairs to define and lead global regulatory strategy with a strong emphasis on PMA pathways.This executive-level role is ideal for a proven regulatory leader with deep experience successfully navigating PMA submissions, IDEs, and complex FDA interactions for high-risk devices. The VP will play a key role on the leadership team, shaping regulatory vision, influencing clinical and development strategy, and driving approvals for innovative technologies with significant patient impact. Key QualificationsBachelor's degree in engineering, life sciences, or related discipline; advanced degree strongly preferred15+ years of regulatory affairs experience within the medical device industry, including senior leadership rolesDemonstrated success leading PMA submissions and securing approvals for Class III devicesDeep expertise in FDA engagement, including pre-submissions, advisory committees, IDEs, and pivotal trial alignmentStrong understanding of clinical trial design and regulatory evidence requirements for high-risk devicesExperience across global regulatory frameworks (FDA, EU MDR, and other international markets)Proven ability to build and execute regulatory strategy across the full product lifecycleExecutive leadership experience, including building, scaling, and mentoring high-performing regulatory teamsExcellent communication skills with the ability to influence at the board and executive level Roles and ResponsibilitiesDefine and execute global regulatory strategy for a portfolio of Class III device programs, with a focus on PMA approvalsServe as the regulatory voice at the executive level, influencing company strategy, clinical development, and commercialization plansLead all FDA interactions, including pre-submissions, formal meetings, advisory panels, and ongoing correspondenceOversee preparation and submission of PMAs, IDEs, and global regulatory filingsProvide strategic guidance on clinical and regulatory requirements, including pivotal study design and evidence generationAssess regulatory risks and develop mitigation strategies to ensure successful product approvals and timelinesPartner closely with Clinical, Quality, R&D, and Commercial teams to align regulatory strategy with broader business objectivesBuild, lead, and scale a best-in-class regulatory organization capable of supporting a growing pipeline BenefitsComprehensive medical, dental, and vision coverage401(k) with company contributionCompetitive PTO and paid holidays