Victoria Walker is recruiting for a Senior Regulatory Affairs Officer to join a textiles manufacturer for the medical devices industry based in Warwickshire, on a full time, permanent basis.
As a Senior Regulatory Affairs Officer, the main purpose of your role will be to become a key player in the addressing regulatory requirements of this company.
Further responsibilities of this Senior Regulatory Affairs Officer will include:
- Developing and executing the regulatory project plan including applicable regulatory submission schedule deliverables
- Preparation of Global Regulatory Strategies to support the registration of new and modified products.
- Preparation of 510(k) submissions and CE Mark Technical files and Design Dossiers.
- Interfacing with customers, Regulatory Authorities and Notified Bodies to address RA questions and submission issues.