Job Description
Job Description
Regulatory Affairs Manager – Medical Device
Location: King of Prussia, PA | Type: Direct Hire
IntePros 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 registrations
- Develop regulatory strategy to optimize approval timelines and labeling
- Guide and grow the Regulatory team’s expertise and performance
- Collaborate across Product Development, Clinical, and Quality teams
- Review/approve change orders, labeling, and Note-to-File documentation
- Support regulatory compliance for manufacturing and product changes
- Maintain and improve regulatory SOPs and team training
- Represent 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 roles
- Proven experience with 510(k), IDE, and PMA submissions (panel-track PMA a plus)
- Strong communication, leadership, and organizational skills
- Detail-oriented with solid computer proficiency
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