1 month ago

Quality Assurance / Regulatory Affairs Officer

Harlow Competitive Permanent

Job Reference: 934917

  • Quality Assurance/Regulatory Affairs Officer
  • Medical Devices
  • Competitive salary

The Client

Our client is a well-established medical device company selling their products worldwide and are looking for a quality assurance/regulatory affairs officer to support all aspects of the quality management system.

The role

In addition to supporting all areas of quality, you will be involved with maintaining regulatory approvals, CAPA administration, risk management and supporting and maintaining technical files.


  • Support the maintenance of the company‚Äôs quality management system
  • Carry out internal and external audits to ISO 13485, MDD 93/42/EEC and 21 CFR Part 820
  • Management of CAPA process
  • Prepare and maintain QMS documentation
  • Liaise with regulatory bodies where necessary
  • Carry out vendor approval audits


  • Experience in a quality role within Medical Devices working to ISO13485
  • Other regulated experience may be considered such as AS9100 or TS16949
  • Experienced at auditing to ISO13485 standard or similar
  • Knowledge of managing CAPA processes and using non-conformance root cause tools
  • Good understanding of GMP
  • Production or manufacturing experience in a medical device environment preferred

Key words

#medicaldevice #iso13485 #qualityassurance #qa #regulatoryaffairs #ra #lifesciences

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