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QA and RA Associate Director (PRRC)

Gateshead, Tyne and Wear   •  Permanent, Full time

CK Group are recruiting for a QA and RA Associate Director to join a leading medical diagnostics company at their site based in Gateshead on a permanent full-time basis.

The Company:
Our client are a market leader in their field and have pioneered advances in technology and instrumentation.

This role is located in Gateshead and the site is easily commutable from the A1(M) and surrounding towns/cities in the North East.

QA and RA Associate Director Role:
Your main duties will be to:

  • Ensure that the requirements of the IVD regulation 2017/746 are met as the Person Responsible for Regulatory Compliance.
  • Act as signatory on the device Declaration of Conformity in line with IVDR requirements.
  • Act as the Qualified Person under the future regulation of medical devices in the UK
  • Act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use, to include emergency change approval, and rework approval.
  • Act as an approver of risk assessments for products and QMS.
  • Act as Management Representative for the site Quality Management System, and acting as Audit contact for external bodies.
  • Act as Regulatory contact with MHRA, FDA and the notified body.

Your Background:
The ideal candidate for this role will:

  • Meet the requirements of Article 15 of EU Regulation 2017/746 to be eligible to perform the PRRC role
  • Have knowledge and experience of Quality Management Systems e.g. ISO 13485, ISO 14971
  • Have knowledge and experience in regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
  • Have an understanding of REACH, CLP, electrical safety standards pertaining to IVD instruments, WEEE and CLSI Guidelines.
  • Have knowledge of requirements of Product Technical files for IVD.
  • Experience with Product Risk Analysis (FMEA?s) and Protocol validation.

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54166 in all correspondence.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 54166
  • Posted: 28th July 2022
  • Expires: 25th August 2022

CK Group

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