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January 7th, 2016

Medical Device Compliance Auditor for Boston or Minneapolis Area

Medical Device Quality and Regulatory Compliance professionals needed for two opportunities to assess non-active medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management

  • 50% Audit
  • Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) and International quality system standards (e.g. ISO 13485)
  • 50% Technical Document Review
  • Perform evaluations of regulatory submissions including: Clinical, Design Dossier, Technical File Review

Requirements:

  • BS Degree in a science related field, advanced degree preferred
  • 5 years of experience in an industrial medical device environment in either Orthopedic Implants, Single Use Medical Devices, Sutures and Staplers, or Catheters
  • 2 years of Quality preferred
  • Direct auditing experience Medical Device Directives is a plus
  • ASQ Certification (CQA, CBA, etc.), ISO 13485 and/or Lead Auditor Certification is desired
  • Regular domestic travel and occasional international travel is required

 

Contact:

Lewie Casey

Talent Manager

MEIRxRS

lcasey@meirxrs.com 818-552-4173

Contact Lewie/Submit Your Resume

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