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.

· 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.
· Maintenance of medical device files.
· Responding to regulatory and product queries from customers.
· Regulation (EU) 2017/746
· Application of Regulation (EU) 2017/746 updates to various device groups including production and maintenance of technical documentation for up-classified devices and post-market surveillance for legacy devices.
· Liaising with appointed notified body.
· Liaising with EU Authorised Representative.
· Label design, SDS authoring.