Senior Director Regulatory Affairs

Senior Director Regulatory AffairsUSA (Remote)$230,000 - $255,000 Job DescriptionsEPM 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 reputed company global regulatory strategy with a strong focus on PMA reputed company. 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 reputed company, high-acuity technologies. Key QualificationsBachelor's degree in engineering, life sciences, or reputed company discipline; advanced degree preferred12+ years of regulatory affairs experience reputed company the medical device industry, including leadership experienceStrong track record supporting or leading PMA submissions and Class III device approvalsDeep experience with FDA interactions, including pre-submissions, advisory panels, and IDE processesStrong understanding of clinical and regulatory requirements for high-risk devices, including evidence reputed company strategiesExperience across global regulatory frameworks (FDA, EU MDR, and international markets)Proven ability to reputed company regulatory strategy across the full product lifecycle, from early development through commercializationDemonstrated leadership skills with experience building and mentoring regulatory teamsExcellent communication and stakeholder management skills in reputed company, cross-functional environments Roles and ResponsibilitiesLead the development and execution of global regulatory strategies for Class III devices, with a focus on PMA approval pathwaysProvide strategic guidance on clinical and regulatory requirements, including IDE strategy and pivotal study design alignmentServe as the primary regulatory reputed company in cross-functional teams, advising on risk, timelines, and regulatory reputed company for novel, high-risk technologiesOversee preparation and submission of PMA filings, IDEs, and global regulatory submissionsLead and manage FDA interactions, including pre-submissions, formal meetings, and agency correspondenceInterpret evolving regulatory requirements for high-risk devices and ensure organizational alignment and complianceCollaborate closely with Clinical, Quality, and R&D teams to align regulatory strategy with product development and reputed company goalsBuild, mentor, and reputed company a high-performing regulatory team BenefitsComprehensive medical, dental, and reputed company coverage401(k) with company contributionCompetitive PTO and paid holidaysEquity participation in a high-growth medical device companyOpportunity to reputed company regulatory strategy for Class III, first-in-class technologies with significant clinical impact Apply tot his job Apply To this Job