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Deputy QA and Regulatory Affairs Manager

CK GROUP
Job LocationGateshead
EducationNot Mentioned
SalarySalary negotiable
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

CK Group are recruiting for a deputy QA / RA Manager on behalf of a well-established medical diagnostic company, to be based at both of their sites in Gateshead and Sunderland 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, Good Manufacturing Practices (including personnel training skills).
  • Experience in the Design and preparation of SOPs.
  • Knowledge and experience of the regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
Apply:It is essential that applicants hold entitlement to work in the UK. Please quote job reference54011in all correspondence.

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