QA & Regulatory Affairs Assistant

Job Ref: J24564
Sector: Science
Sub-sector: Biotech/Life Sciences
Date Added: 05 December 2017
  • Sunderland, Tyne and Wear, England, UK
  • Competitive
  • Daniel Ball
  • 0191 284 6768

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QA & Regulatory Assistant

Salary Dependent on Experience


A leading Medical Device organisation are looking to recruit a QA & Regulatory Assistant to work within the QA Department performing a range of QA tasks at their site in Sunderland.

The QA & Regulatory Assistant will work with the production team approving all production documentation along with all departmental SOPs. They will be instrumental in all global registration related activities and assist in the maintenance of the Quality Management System. Alongside this they will maintain the interface with the MHRA and participate in the preparation of Safety Data Sheets and associated documentation.

The successful candidate will have knowledge of Quality Management Systems or regulatory requirements, preferably ISO13485 or ISO9001, or IVDD (98/79/EC). Knowledge of the US Quality System Regulation or FDA regulations would be beneficial but not essential. A sound working knowledge of GMP would be preferable, as would knowledge of the requirements of Product Technical files for IVD.

If you are an experienced individual working within QA or Regulatory Affairs, please apply online or call Dan on 0191 284 6768.

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.