Vice President Regulatory Affairs

Vice President, Regulatory Affairs

USA (Remote)

$300,000 - $350,000 + Bonus + Equity

Job Description

EPM 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 Qualifications

• Bachelor's degree in engineering, life sciences, or related discipline; advanced degree strongly preferred
• 15+ years of regulatory affairs experience within the medical device industry, including senior leadership roles
• Demonstrated success leading PMA submissions and securing approvals for Class III devices
• Deep expertise in FDA engagement, including pre-submissions, advisory committees, IDEs, and pivotal trial alignment
• Strong understanding of clinical trial design and regulatory evidence requirements for high-risk devices
• Experience across global regulatory frameworks (FDA, EU MDR, and other international markets)
• Proven ability to build and execute regulatory strategy across the full product lifecycle
• Executive leadership experience, including building, scaling, and mentoring high-performing regulatory teams
• Excellent communication skills with the ability to influence at the board and executive level

Roles and Responsibilities

• Define and execute global regulatory strategy for a portfolio of Class III device programs, with a focus on PMA approvals
• Serve as the regulatory voice at the executive level, influencing company strategy, clinical development, and commercialization plans
• Lead all FDA interactions, including pre-submissions, formal meetings, advisory panels, and ongoing correspondence
• Oversee preparation and submission of PMAs, IDEs, and global regulatory filings
• Provide strategic guidance on clinical and regulatory requirements, including pivotal study design and evidence generation
• Assess regulatory risks and develop mitigation strategies to ensure successful product approvals and timelines
• Partner closely with Clinical, Quality, R&D, and Commercial teams to align regulatory strategy with broader business objectives
• Build, lead, and scale a best-in-class regulatory organization capable of supporting a growing pipeline

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) with company contribution
• Competitive PTO and paid holidays