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Job

Regulatory Affairs Manager

  • Job ref:

    11448

  • Location:

    Peterborough, United States

  • Sector:

    Quality Engineers

  • Contact:

    Bob Giusti

  • Published:

    4 months ago

  • Consultant:

    #

Regulatory Affairs Manager

 

Responsibilities include:

  • Develop regulatory strategies to support operational objectives for US and international marketing and sale.
  • Review new and modified devices for fulfillment of regulatory obligations: FDA, European MDD/MDR, CE, PMDA, and Canadian CMDR.
  • Review new and modified devices for fulfillment of appropriate standards for electrical, mechanical, material and software safety: ISO, UL, IEC.
  • Prepare regulatory documents required for timely completion of regulatory submissions that could include some or all of the following: pre-submissions, PMA, 510(k), IDE and technical file for Notified Body.
  • Maintain appropriate domestic and international registrations and product listings.
  • Support post-market corrective actions.

 

Qualifications/Specifications:

  • Bachelor’s Degree – preferably in Life Sciences or Engineering disciplines
  • Minimum 5 years medical device industry experience in a regulatory affairs role
  • Thorough understanding of medical device agency regulations: FDA’s medical device regulation (21 CFR Part 820), CE, European MDD/MDR, PMDA, CMDR
  • Working knowledge of applicable medical device standards. E.g.: ISO 13485, ISO 14971, IEC 60601, IEC 62304.
  • Experience developing successful regulatory strategies.
  • Experience interfacing directly with the FDA, international regulatory agencies and notified bodies.