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Job Location | Stirling |
Education | Not Mentioned |
Salary | £40,000 - £50,000 per annum |
Industry | Not Mentioned |
Functional Area | Not Mentioned |
Job Type | Permanent, full-time |
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.Role DescriptionReporting 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.Responsibilities
Keyskills :
Medical Devices Regulaty Affairs CE Marking ISO 3485 14971 FDA 21CFR IVD/IVDR