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Regulatory affairs/qa coordinator, medical devices

Birkenhead
Permanent
Russell Taylor Management
Coordinator
Posted: 13 May
Offer description

Regulatory Affairs/QA Coordinator, Medical Devices Type: Permanent Location: Wirral (onsite role) Salary: £30,000 - £35,000 (depending on experience) Additional: 25 days holiday, NEST pension scheme, 6 month probation Our Client, a growing medical devices company are looking to appoint a RA Coordinator who will play an integral role in the continued development of the QMS & regulatory functions, working cross functionally across the QA/RA/ QC teams. This is a fantastic role for someone with experience in basic QA/RA duties (CAPA, deviations, raising non-conformances etc) to move into a full time RA role or someone with this experience to continue & develop in their career, working in an SME setting - given the autonomy to succeed in a positive environment. The Role: • Maintenance and implementation of ISO 13485:2016 certified quality management system (QMS) including where required writing and updating SOP's and associated Forms. • Conducting internal audits of the QMS. • Overseeing external (surveillance and certification) audits of the QMS conducted by current registrar. • Documenting customer complaints. • Conducting and documenting product recalls. • Documenting and implementing corrective and preventive action /CAPA • Documenting nonconformances. • Completing management review submissions. • Completing design and development documentation. •...

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