Quality Assurance and Regulatory Affairs Specialist (Medical Devices)
Ref : 20014
Our NW based Medical Device client are actively looking for a QA and Regulatory Affairs Specialist.
Duties for this role will include:-
- Ensuring compliance with regulations / standards and guidelines (ISO 13485, MDD, FDA 21 CFR 820)
- Developing and maintaining Quality Manual and other related processes
- Ensuring 3rd party activities also comply with regulations
- Deputising for the QA and Regulatory Manager
- Assisting and advising in customer complaint investigations
- Developing and maintaining supplier management systems
- QA Training
- Investigating manufacturing problems
- Managing relationships to ensure product is manufactured to agreed specifications and standards
- CAPA / Change Control
Applications are invited from candidates with a BSc in a scientific subject, together with previous suitable skills and abilities working with Medical Devices.
This is a permanent position, offering a salary of up to £40,000 (depending on skills and experience).
Role : Permanent
Location : NW
Salary : Up to £40,000 (depending on skills and experience)
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