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| Job Location | London |
| Education | Not Mentioned |
| Salary | Salary negotiable |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Contract, full-time |
Austin Vita are engaged with a small / medium sized Medical Devices company, based in London that are looking to go live on their MDR transition. The bulk of the work has been completed, however, they are at a stumbling block when it comes to the Design History File remediation (there are legacy files in need of transitioning).The project is forecasted to last around 4 months, with a view to extend thereafter to ensure the proper maintenance of this project. It is also fully remote-based working from your own home / office.This client is in pursuit of a QARA specialist with a great aptitude with DHFs and the MDR standards, who is able to move these files from MDD to MDR as best as possible, while also providing insight and education to the wider QARA department as to how/where/why these changes are being made.They are looking for someone to realistically start ASAP, however, with Christmas approaching fast they are prepared to have a buffer in start date with the beginning of January being the latest they can do.Apply below if you match these skills:- Proven track record remediating, compiling and reviewing Design History Files / Design Dossiers- Knowledge of the MDR- Wider knowledge of the ISO 13485 lifecycleAustin Fraser is acting as an Employment Business in relation to this vacancy.Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants. Required skills
Keyskills :
MDR RD quality medical devices regulaty research and development DHF medtech design histy files