Deputy QA and Regulatory Affairs Manager
2 weeks ago
CK Group are recruiting for a deputy QA / RA Manager on behalf of a well-established medical diagnostic company, to be based at both of their sites in Gateshead and Sunderland on a permanent basis.
**Your duties will include**:
- Achieving and maintaining compliance with IVDR, IVDD and ISO 13485
- Approval of production documentation and associated artwork/documentation for use internally and externally
- Approval of SOPs, and raising new procedures as required
- Management of global registration related activities, including producing country specific documents and acting as signatory on behalf of the company.
- Maintenance of the QMS
- Acting as the interface with the MHRA website for certificates of free sale.
- Registration of new products and/or significant changes with relevant regulatory authorities
- Ensuring that the company is Audit ready at all times.
**Key Skills Required**:
- Experience in QA or RA within a relevant industry (i.e. Diagnostics, Medical Devices or Pharmaceutical)
- Solid working knowledge of Quality Management Systems, Good Manufacturing Practices (including personnel training skills).
- Experience in the Design and preparation of SOPs.
- Knowledge and experience of the regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 54011 in all correspondence.
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