Senior Director Regulatory Affairs

Senior Director Regulatory Affairs

USA (Remote)

$230,000 - $255,000

Job Descriptions

EPM is partnered with an innovative medical device company developing first-in-class, high-impact technologies targeting significant unmet clinical needs. With a pipeline spanning early feasibility through commercialization, including Class III devices, the organization is seeking a Senior Director of Regulatory Affairs to lead global regulatory strategy with a strong focus on PMA pathways. This is a critical leadership role for a seasoned regulatory professional with deep experience navigating high-risk device approvals, including PMA submissions, IDEs, and FDA engagement for novel products. The position offers the opportunity to work cross-functionally with R&D, Clinical, and Quality teams to drive regulatory strategy for complex, high-acuity technologies.

Key Qualifications

• Bachelor's degree in engineering, life sciences, or related discipline; advanced degree preferred
• 12+ years of regulatory affairs experience within the medical device industry, including leadership experience
• Strong track record supporting or leading PMA submissions and Class III device approvals
• Deep experience with FDA interactions, including pre-submissions, advisory panels, and IDE processes
• Strong understanding of clinical and regulatory requirements for high-risk devices, including evidence generation strategies
• Experience across global regulatory frameworks (FDA, EU MDR, and international markets)
• Proven ability to lead regulatory strategy across the full product lifecycle, from early development through commercialization
• Demonstrated leadership skills with experience building and mentoring regulatory teams
• Excellent communication and stakeholder management skills in complex, cross-functional environments

Roles and Responsibilities

• Lead the development and execution of global regulatory strategies for Class III devices, with a focus on PMA approval pathways
• Provide strategic guidance on clinical and regulatory requirements, including IDE strategy and pivotal study design alignment
• Serve as the primary regulatory lead in cross-functional teams, advising on risk, timelines, and regulatory pathways for novel, high-risk technologies
• Oversee preparation and submission of PMA filings, IDEs, and global regulatory submissions
• Lead and manage FDA interactions, including pre-submissions, formal meetings, and agency correspondence
• Interpret evolving regulatory requirements for high-risk devices and ensure organizational alignment and compliance
• Collaborate closely with Clinical, Quality, and R&D teams to align regulatory strategy with product development and commercial goals
• Build, mentor, and lead a high-performing regulatory team

Benefits

• Comprehensive medical, dental, and vision coverage
• 401(k) with company contribution
• Competitive PTO and paid holidays
• Equity participation in a high-growth medical device company
• Opportunity to lead regulatory strategy for Class III, first-in-class technologies with significant clinical impact