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Regulatory Affairs Manager

Gateshead, Tyne and Wear   •  Permanent, Full time

CK Group are recruiting for a Regulatory Affairs Manager 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.

Regulatory Affairs Manager Role:
Your main duties will be:

  • To ensure the company meets IVDR and IVDD compliance and ISO 13485 standard.
  • To act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use.
  • To act as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary.
  • To assist with the maintenance of the site Quality Management System
  • To manage all Safety Data Sheets (MSDS) and associated documentation, and advise on Dangerous Goods Transport.
  • Regular review and company notification of regulatory legislation and guidelines.
  • To work with the quality and production teams to ensure product regulatory requirements are met.

Your Background:
The ideal candidate for this role will have:

  • At least 2 years experience and background in medical device or pharmaceutical regulatory affairs management.
  • Knowledge and experience of Quality Management Systems e.g. ISO9001, ISO 13485 and the US Quality System Regulation.
  • Knowledge and experience in regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
  • Sound working knowledge of Good Manufacturing Practices, including personnel training skills.
  • Design and preparation of Standard Operating Procedures.
  • Sound working knowledge of Safety Data Sheet requirements.

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54165 in all correspondence.

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

  • Agency: CK Group
  • Reference: 54165
  • Posted: 29th July 2022
  • Expires: 26th August 2022

CK Group

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