Job Description
Main Purpose of Job
* Responsible for R&D activities related to the development and launch of new innovations.
* Responsible for R&D activities related to supporting the compliance of GBUKs existing medical device portfolio.
* Supporting the business in design history, product and production validation and verification and technical transfer of medical devices.
* Responsible for generation and maintenance of technical documentation and the design history file to ensure compliance to all current Medical Device regulations and ISO 13485 requirements.
Main Tasks/Responsibilities
1. To provide accurate and current Research & Development input to support with the development and compliance of medical devices launched and marketed by GBUK.
2. Responsible for generation of documentation in the areas of design history, product and production validation and verification, risk management, hazard analysis, usability and technical transfer.
3. Responsible for writing and maintaining user requirement specifications and Risk analysis documentation.
4. Responsible for working with external partners, such as laboratories, to run studies, ensuring the studies are planned correctly and delivered to agreed timings.
5. Responsible for communicating with suppliers to ensu...