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Regulatory Affairs Consultant
2 weeks ago
CK Group are recruiting for Regulatory Affairs Executive to join a world leading pharmaceutical company working remotely on an initial 12-month contract. This role has been deemed inside IR35.
**This Regulatory Affairs executive role contributes to the success of UK & Ireland organisation**:
- Ensuring that all products are in regulatory compliance with country specific legislation
- Ensuring that all post market surveillance processes are fit for purpose and adhered to
**Key Responsibilities**:
- Develop and maintain country specific product regulatory processes including device registration, data/record management, post market surveillance and vigilance
- Compliance with and implementation of Global Quality and Regulatory processes
- Training of Regional Customer Support Centre Teams on case quality, potentially reportable incident reporting
- Communication with National Competent Authorities
- Review and implementation of new legislation/regulations applicable to UK and Ireland
**Your Background**:
- Life sciences Degree or equivalent
- Regulatory Affairs experience in Medical Device or diagnostics industry
- Working with Notified Bodies
- Medical Device Registration
- Understanding of the current IVD Regulatory Framework and processes, UK and EU
- Communication with Competent Authorities
**Apply**:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference 53795 in all correspondence.
