Back to searchRegulatory Affairs/QA Coordinator, Medical Devices
Russell Taylor Group Ltd
Posted a day ago, valid for a month
Prenton, Merseyside CH43 0XF
£30,000 per annum
Full Time
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Sonic Summary
- The Regulatory Affairs/QA Coordinator position is a permanent role based in Wirral, with a salary ranging from £30,000 to £35,000 depending on experience.
- The successful candidate will have experience in basic QA/RA duties such as CAPA and non-conformances, ideally with a background in a medical device ISO 13485 setting.
- Key responsibilities include maintaining the ISO 13485:2016 certified quality management system, conducting internal audits, and overseeing external audits.
- Candidates should possess a degree in a relevant scientific or STEM discipline and demonstrate strong IT literacy and communication skills.
- This role offers 25 days of holiday, a NEST pension scheme, and a 6-month probation period.
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.
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.
The Person:
Will hold a degree in a relevant/ Scientific/STEM related discipline.
Experience working in a medical device- ISO 13485 setting, IVD/ IVDR or similar setting/
The ideal Candidate will have experience in CAPA, OOs, OOt, raising non-conformances, SOP write up etc or similar
We need a decent level of IT literacy for the role; half of the QMS is the electronic/ LIMS etc the other is paper based. For this reason, we require a high standard of written and verbal English language too to ensure effective communication with the relevant teams, suppliers/ customers and/or relevant notified body.
Strong interpersonal skills.
Multi-task oriented.
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