Description
To be considered for this role it is essential that you have: previous- Regulatory Affairs experience from a medical devices environment
- GMP validation practises
- Technical file reviews, Declaration of Conformity & CE marking
- VMP, protocol, SOP and report writing
- Lead auditing and inspection (both internal and third party).
- Clinical studies
- Experience of dealing directly with Notified Bodies (MHRA & FDA)
- FDA CFR 820 and EC Medical Devices Directive 93/42/EEC experience
To discuss this role further please get in contact with Oliver Davies from Real Staffing on , or send an up to date CV with a covering letter regarding this role.
I look forward to your response.