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Regulatory Affairs and Safety Documentation Controller

Tyne and Wear   •  Permanent, Full time

CK Group are recruiting for a Regulatory Affairs and Safety Documentation Controller to join a leading medical diagnostics company at their site based in Gateshead on a permanent 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 and Safety Documentation Controller Role:
Your main duties will be to:

  • Meet IVDR and IVDD compliance and the ISO standard and manage all Safety Data Sheets (MSDS) and associated documentation and advise on Dangerous Goods Transport.
  • Manage all COSHH regulatory requirements and associated COSHH Risk Assessment documentation.
  • Act as an approver of production documentation and associated artwork/documentation used by the end customer and for internal use, and to make the documents effective, where outside Q-Pulse if required as well as acting as an approver of site and departmental standard operating procedures, and to raise new procedures where necessary.
  • Manage and facilitate with all global registration related activities, including producing country specific documents where required and acting as signatory on behalf of the company.

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

  • Educated to degree level or above in life science or a related field with previous experience in a similar role and knowledge and experience of Quality Management Systems and 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, Safety Data Sheet requirements and COSHH risk assessments.
  • A confident decision-maker, able to communicate well with all personnel within the company and competent in the use of the Internet and Microsoft Windows programs including Word, Excel and PowerPoint.

For more information or to apply for this Regulatory Affairs and Safety Documentation Controller position, please contact Mary Bolt on 01246 457729 or email mbolt@ckgroup.co.uk, quoting job ref 51019

It is essential that applicants hold entitlement to work in the UK

You must be eligible to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Mary Bolt
  • Phone: 01438 743047
  • Reference: 51019
  • Posted: 1st July 2021
  • Expires: 29th July 2021

CK Group

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