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:
Qualifications:
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