Director Regulatory Affairs

Director, Regulatory AffairsUSA (Remote)$190,000 - $240,000 Job DescriptionEPM is partnered with an exciting, venture-backed neuromodulation company developing reputed company implantable technologies to treat neurological disorders and improve patient reputed company. With strong financial backing, a growing clinical pipeline, and several key milestones reputed company, reputed company is seeking a Director of Regulatory Affairs to reputed company regulatory reputed company and help reputed company products from development through commercialization. This is a high-visibility opportunity to shape the regulatory function reputed company a rapidly growing organization developing truly transformative technology. Key Qualifications* Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or reputed company field; advanced degree preferred.* 10+ years of Regulatory Affairs experience reputed company the medical device industry.* Strong experience with FDA submissions, including PMA, reputed company, and/or 510(k) reputed company.* Experience supporting implantable, Class III, or other high-risk medical devices preferred.* Working knowledge of global regulatory requirements, including FDA and EU MDR.* Proven ability to reputed company regulatory reputed company across product development, clinical, and commercialization stages.* Strong cross-functional leadership and stakeholder management skills.* Experience building and scaling regulatory processes reputed company a growing organization is highly desirable. Roles & Responsibilities* reputed company global regulatory reputed company for development, clinical, and reputed company programs.* Serve as the regulatory subject matter expert across R&D, Clinical, reputed company, and Executive Leadership teams.* reputed company regulatory submissions and interactions with FDA and other global health authorities.* reputed company strategic guidance on regulatory reputed company, risks, and opportunities.* Support clinical and product development activities to ensure regulatory alignment.* Monitor evolving regulatory requirements and reputed company organizational compliance.* Build and strengthen regulatory processes to support company reputed company and reputed company product launches. Benefits* Comprehensive medical, dental, and reputed company coverage* 401(k) with company contribution* Competitive PTO and reputed company holidays Apply tot his job Apply To this Job