Regulatory Affairs Specialist - Medical Devices
Our client is a rapidly growing medical device company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. The company has major operations in the UK and the USA, and is supported by a global sales network with over 700 employees worldwide.
Reporting to the Quality and Regulatory Director, the successful candidate shall be responsible for the regulatory activities for the legal manufactured products associated with IVD medical devices (assays, instruments, software and ancillary items relating to the system) development through the R&D phase and the verification and validation phase through launch and post marketing arena.
Activities such as requirements generation document/process creation, review and approval of documents and working with all project teams to guide the teams in the day to day development and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the development.
- Creation and management of technical files of all legal manufactured products
- Creation of QA/RA plans for the design and development teams to support Global markets up to the formation of the standard dossier.
- Creation and maintenance of harmonised standards compliance plans
- QMS updates required for higher risk IVD's such as PMA and WHO pre-qualification programme activities.
- Review and approval of change requests for regulatory impact assessment
- Creation of process for the management of approval of global marketing collaterals and localisation process
- Review and approval of marketing collateral
- Knowledge and experience of working to the appropriate quality and regulatory standards including ISO 13485, ISO 14971, FDA 21CFR part 820, IVD 98/79/EEC/IVDR
- Development and writing of CE marking technical files
- Knowledge of Adverse event reporting in clinical environment
- Detailed knowledge of post market regulatory activities including FSCA, incident reporting
- Experience and knowledge of vertical and horizontal standards for IVD medical device instruments and assays in the point of care.
- Experience of working in an IVD or medical device design and manufacturing environment
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales