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Sr. Regulatory Affairs

Job Attributes

Job Id:

32836

Job Category:

Biotechnology

Job Location:

Somerville, NJ  08807

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions

JOB DESCRIPTION


Piper Companies is currently looking for an experienced Sr. Regulatory Affairs Specialist in Somerville, NJ to work for an innovative and growing medical device manufacturer. The Regulatory Affairs Specialist will play in pivotal role in the development of new medical implants and the revision of legacy products


Responsibilities for the Sr. Regulatory Affairs Specialist include:

  • Cooperate with the product development and management teams to prepare/ review 510k submissions
  • Work with personnel in various functional areas to obtain timely submissions to FDA
  • Prepare, support, and maintain technical rules in accordance with MDR.
  • Review and file Note-to-File documentation for minor changes to 510(k) cleared products or systems.
  • Assist in the preparation of FDA reports and or other documentation.
  •  Ensure conformance to 21 CFR regulations, 1S013485,1S014971, & EU MDR.


Qualifications for the Sr. Regulatory Affairs Specialist include:

  • BS or higher degree in Regulatory Affairs 
  • 2+ years of experience in the medical device experience
  • Hands on experience with 510k submissions


Compensation for the Sr. Regulatory Affairs Specialist include:

  • Salary Range is dependent upon experience
  • Comprehensive benefits package


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Job Id:

32836

Job Category:

Biotechnology

Job Location:

Somerville, NJ  08807

Security Clearance:

None

Business Unit:

Piper Companies

Division:

Piper Clinical Solutions