Regulatory Affairs Manager, Medical Device

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 :