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Regulatory Affairs Specialist, Biotech

Location: United States,
Reference ID:

Our Global Medical Device client focused on women’s health, Surgical Solutions, Genomics, and Reproductive Health are in a new growth phase and the RA team is under new direction and strong leadership.  We are supporting her team for a hybrid position as a Regulatory Affairs Specialist to support RA compliance and QMS activities and the manufacturing site transitions to a Pharma compliance/regulated location including assisting in internal audits, vendor qualification processes, and involvement in developing and supporting quality and regulatory systems.

The Right Talent:

BS in Science, Engineering or Relevant Degree

3+ years of Pharma, Biotech or Medtech experience in regulatory affairs, compliance, and/or quality

Experience with auditing, regulatory compliance, research, and gap analysis for regulations

Experience with regulatory compliance, contract oversight, and product labeling 

Interest growing a career in regulatory affairs 

Strong communication skills and attention to detail 


This position can be remote with limited travel

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