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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