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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.

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.

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.

Apply:
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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