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Deputy QA / RA Manager

Tyne and Wear   •  Permanent, Full time


CK Group are recruiting for a deputy QA / RA Manager on behalf of a well-established medical diagnostic company, to be based at their site in Gateshead on a permanent basis.

Your duties will include:

  • Achieving and maintaining compliance with IVDR, IVDD and ISO 13485
  • Approval of production documentation and associated artwork/documentation for use internally and externally
  • Approval of SOPs, and raising new procedures as required
  • Management of global registration related activities, including producing country specific documents and acting as signatory on behalf of the company.
  • Maintenance of the QMS
  • Acting as the interface with the MHRA website for certificates of free sale.
  • Registration of new products and/or significant changes with relevant regulatory authorities
  • Ensuring that the company is Audit ready at all times.

Key Skills Required:

  • Experience in QA or RA within a relevant industry (i.e. Diagnostics, Medical Devices or Pharmaceutical)
  • Solid working knowledge of Quality Management Systems
  • Knowledge and experience of the regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.

For more information, or to apply for this position, please contact Sarah Farrow on 0191 3706486 or sfarrow@ckgroup.co.uk, quoting job ref 50280.

INDGEN


You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Sarah Farrow
  • Phone: 0191 384 8906
  • Reference: 50280
  • Posted: 30th March 2021
  • Expires: 27th April 2021

CK Group

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