Job Title: Scientist / Senior ScientistReporting to: Senior Manager, Product DevelopmentLocation: CambridgeTerms: PermanentSalary: DOE starting at £30k/annumThis is an exciting opportunity to join a ground...
Quality Assurance & Regulatory Affairs Manager
A new and exciting opportunity has emerged in an up-and-coming medical device company based in Cambridge UK.
The Quality Assurance & Regulatory Affairs Manager will be responsible for the company's QMS, operating procedures and risk management. The successful candidate will also contribute to the R&D and manufacturing team.
Location: Cambridge, UK
Salary: £40,000 - £50,000
Start - ASAP
- Manage Regulatory Compliance
- Manage and develop QMS
- Review and manage SOPs
- Manage manufacturing and procurement from a quality perspective
- Manage and update QA systems
- Drive risk management initiatives
- Manage employee QMS training
- Manage internal audit programme and host regulatory inspection
- Contribute to the R&D process
- BSc / MSc / PhD degree or equivalent in Molecular Biology or similar field
- Experience in an Medical Device or In vitro Diagnostics (IVD) environment
- ISO13485, IVDD 98/79/EC, MDD 93/42/EEC, GCLP, FDA Reg: CFR part 820 experience
- Strong GCP knowledge of clinical trials regulations
- Knowledge and Experience of medical device manufacturing and supply chain requirement
- Expirence in CE marking
If this represents an opportunity you would be interested in and your CV reflects the key areas mentioned above then please apply now by attaching your CV in MS Word format.
Alternatively, for more information on this role, please contact Dominic Cappell Dominic.Cappell@srg.co.uk / 01223 607857.