Are you a Process Operator looking for a new role? I am currently recruiting for a Process Operator working for a company who are based...
Are you an experienced medical devices project manager, looking for a new challenge? An innovative start-up based in Cambridge need you!
This company work in a very different way to most others in the medical device arena. They start by speaking directly with clinicians in local hospitals, to understand the issues they're facing. Following this, funding is injected to develop, trial and obtain regulatory approval for a product able to solve the problems highlighted. To date they have 4 products and the cycle from concept to delivery has taken 12 months!
As the Project Manager you will be responsible for leading the successful delivery of product development projects to targets including scope, cost, schedule and quality. This involves stakeholder management, including reporting internally in addition to close collaboration with third parties such as NHS clinicians, academics, CRO's, CDMO's, CMO's and suppliers.
Skills and experience required:
- Track record of leading and managing full-lifecycle medical device product development projects e.g. from concept, through design and development, clinical trial, regulatory approval, stable manufacture and market launch
- Developing class I, IIa, IIb medical devices
- Demonstrate some knowledge of the UK, EU, US and other international medical device regulatory requirements e.g. MDD, MDR, FDA 510k, Risk Management (14971), Electrical Safety (60601), Software Lifecycle (62304) and sterile devices standards
- Ability to travel independently to venues around the UK at times and for durations required by the role. This may require the post holder to be away from the main base of operations for overnight periods and may also include international travel.
Submit your CV today to express your interest!