CK Group are recruiting for a deputy QA / RA Manager on behalf of a well-established medical diagnostic company, to be based at their site in Gateshead 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
- Knowledge and experience of the regulatory requirements according to ISO 13485, IVDD (98/79/EC), IVDR 2017/746 and FDA Quality Systems Regulation.
For more information, or to apply for this position, please contact Sarah Farrow on 0191 3706486 or email@example.com, quoting job ref 50280.
You must be eligible to work in the UK. Learn more
- Agency: CK Group
- Contact: Sarah Farrow
- Phone: 0191 384 8906
- Reference: 50280
Website: CK Group
- Posted: 30th March 2021
- Expires: 27th April 2021