Director Regulatory Affairs

Director, Regulatory AffairsUSA (Remote)$190,000 - $240,000 Job DescriptionEPM is partnered with an innovative, venture-backed medical device company focused on developing cutting-edge technologies that address unmet clinical needs across multiple therapeutic areas. With a strong pipeline of novel products spanning early feasibility through commercialization, the organization is seeking a Director of Regulatory Affairs to lead global regulatory strategy and execution. This is a high-impact leadership role offering the opportunity to work cross-functionally with R&D, Clinical, and Quality teams to bring transformative devices to market. The position is ideal for a seasoned regulatory professional who thrives in a fast-paced, growth-oriented environment and is looking to play a key role in shaping regulatory pathways and company strategy. Key Qualifications* Bachelor's degree in engineering, life sciences, or related discipline; advanced degree preferred.* 10+ years of regulatory affairs experience within the medical device industry, including leadership experience.* Proven track record of leading successful FDA submissions (e.g., 510(k), PMA, De Novo) and interacting directly with regulatory agencies.* Strong knowledge of global regulatory requirements, including FDA, EU MDR/IVDR, and international frameworks.* Experience developing and executing regulatory strategies across product lifecycle stages (development through commercialization).* Demonstrated leadership skills with the ability to build, mentor, and manage regulatory teams.* Excellent communication and stakeholder management skills, with experience influencing cross-functional decision-making. Roles & Responsibilities* Develop and lead global regulatory strategies to support product development, clinical studies, and market approvals.* Serve as the primary regulatory representative in cross-functional teams, providing guidance on regulatory pathways and risks.* Oversee preparation and submission of regulatory filings to FDA and global agencies, ensuring timelines and compliance requirements are met.* Manage regulatory interactions, including pre-submissions, meetings, and agency correspondence.* Interpret new and evolving regulatory requirements and ensure organizational readiness and compliance.* Collaborate closely with Clinical, Quality, and R&D teams to align regulatory strategy with product and business objectives.* Lead and mentor a team of regulatory professionals, fostering growth and development. 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 innovative, first-in-class technologies