Regulatory Compliance Expert

4 days ago


Cardiff, Cardiff, United Kingdom Gyrus Medical Limited Full time
Role Summary:

The successful candidate will have a minimum of 3 years' experience working in a QA/QS environment, preferably within the medical device or pharmaceutical industry, and knowledge of ISO13485:2003 and Medical Device Directive MDD 93/42/EEC. As a Regulatory Compliance Expert, you will provide advice according to established procedures relating to CAPA, Complaint, Post Market Surveillance and NCR, and against the external requirements of the relevant regulatory authority.

This is a fantastic opportunity to work with a dynamic team, where you will be responsible for reviewing and authorising documentation and processes in the Quality Management System to ensure compliance with established quality procedures and applicable regulations.

We offer a competitive salary of £50,000 - £65,000 per annum, depending on experience, plus hybrid working arrangements, bonus scheme, generous pension scheme, free life assurance, private medical insurance, 25 days annual leave (plus bank holidays), and an employee assistance programme.



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