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Regulatory Affairs Manager

Industry: Life Sciences

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Regulatory Affairs Manager

My client is a one of the oldest Medical Device companies worldwide.  Their longevity is due to a strong leadership team and core commitment to maintaining strong products in order to assure the company’s longevity. The Regulatory Affairs Manager will be reporting directly into the VP of Corporate Regulatory Affairs and will be responsible for an entire product line around infusion pumps. If you are looking for a great company that offers a variety of strong products as well as a stable work environment, this is company position for you.   

Job Responsibilities:

  • Prepare regulatory submissions (5100(k), PMA) to secure FDA marketing clearance.
  • Support entire product line around software controlled devices
  • Cross functional interaction with other Regulatory teams
  • Coordinate electronic submissions for assigned product line
  • Insure product line’s compliance to all applicable regulations and standards

Job Requirements:

  • B.S. in Scientific or Technical discipline, B.S. Engineering preferred
  • Minimum 7 years experience in Medical Device industry
  • Minimum 4 years experience in Regulatory Affairs
  • Experience working with Software Controlled Medical Devices required
  • Experience working with infusion pumps highly desired
  • Experience creating and maintaining Regulatory Submissions

Location:

  • Philadelphia, PA 

For confidential consideration, please forward your resume in a Word document to jharris@kleinhersh.com only qualified candidates will be contacted.

Visit www.kleinhersh.com to view other job opportunities available through our company.

For additional information about this job, please contact: jharris@kleinhersh.com