About this opportunity
Actalent lists this Lead Regulatory Affairs – Medical Devices (510(k)/PMA) opportunity in lower providence township, Pennsylvania. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Actalent in Audubon, PA is seeking a Senior Clinical Regulatory Specialist to lead U.S. premarket submissions for Class II and III devices, with emphasis on 510(k) filings and FDA interactions.
You will coordinate cross-functional teams across Product Development, Clinical, Quality, and Engineering, mentor staff, and ensure timely, compliant regulatory deliverables for IDE, PMA, and post-approval activities.
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.