Regulatory Affairs Officer

7 days left

CK Group
02 Sep 2020
30 Sep 2020
James Horne
Contract Type
Full Time
CK Science are recruiting for a Regulatory Affairs Officer to join a leading medical diagnostics company at their site based in Sunderland 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 Sunderland and the site is easily commutable from the A1(M)/A19 and surrounding towns/cities in the North East.

Regulatory Affairs Officer Role:
Your main duties will be to:

- Ensure master product documentation is available in a timely manner as directed by the production plan and to assist with ensuring that the company is Audit ready at all times.
- 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.

Further responsibilities will include:

- Assisting with the maintenance of the site Quality Management System, including updating of documentation and providing training where necessary, including site induction training.
- Participating in the preparation of Safety Data Sheets and/or act as an approver of Safety Data Sheets and associated documentation and advise on Dangerous Goods Transport.
- Maintaining interface with MHRA website for certificates of free sale, maintaining licence requirements with Home Office and regularly reviewing and company notification of regulatory legislation and guidelines, other than IVDR 2017/746.

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

- Education 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 (e.g. ISO 9001, ISO 13485) and the US Quality System Regulation, as well as 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 and Safety Data Sheet requirements.
- 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 Officer position, please contact James Horne on 0191 384 8905 or email, quoting job ref 48817.

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

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