Director Regulatory Affairs
Director, Regulatory Affairs
USA (Remote)
$190,000 - $240,000
Job Description
EPM 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
FAQs
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