Regulatory Affairs Manager, Medical Device

Regulatory Affairs Manager - Medical DeviceLocation: King of Prussia, PA | Type: Direct HireIntePros is seeking a Regulatory Affairs Manager for a growing medical device company. This is a direct hire opportunity. Medical device experience is a must. This role leads the preparation and submission of 510(k), IDE, and PMA filings for Class II and III devices, ensuring compliance with FDA 21 CFR regulations. You'll collaborate with cross-functional teams and represent the company in FDA communications and meetings.Note: No C2C or third-party submissions.Key Responsibilities:Lead and manage U.S. regulatory submissions (510(k), IDE, PMA) and global registrationsDevelop regulatory strategy to optimize approval timelines and labelingGuide and grow the Regulatory team's expertise and performanceCollaborate across Product Development, Clinical, and Quality teamsReview/approve change orders, labeling, and Note-to-File documentationSupport regulatory compliance for manufacturing and product changesMaintain and improve regulatory SOPs and team trainingRepresent company in FDA meetings and ensure full compliance with applicable regulations and codes (21 CFR, AdvaMed, etc.)Qualifications:Master's in engineering or science field (or equivalent)8+ years in the medical device industry, including 3+ in regulatory rolesProven experience with 510(k), IDE, and PMA submissions (panel-track PMA a plus)Strong communication, leadership, and organizational skillsDetail-oriented with solid computer proficiency

Created: 2025-10-02