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QA and RA Associate Director PRRC

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 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.Location: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 (FMEAs) and Protocol validation.
Apply:It is essential that applicants hold entitlement to work in the UK. Please quote job reference54166in all correspondence.

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