Medical Device Project Manager

Salary: £48,000 – £50,400 per year

Medical Device Project Manager
Homebased
12 months contract with possible extension / permanent position, full or part time option
£Competitive
Opportunity:
An up-and-coming medical device company in the field of medical imaging is approaching completion of prototype development and now need an experienced Medical Device Project Manager to navigate the project team through design verification and validation and then regulatory submissions.
Your role as a Medical Device Project Manager will include
* Planning all cross functional project activities leading to regulatory approval, including time lines, budgets and project risk management.
* Coordinating activities of the internal project team and external partners.
* Monitoring progress and making recommendations for corrective actions where needed to keep the project on track.
* Organisation and day-to-day management of the Design History File and Risk Management Plan.
* Management of Change Control.
* Leading the project team through formal design and milestone review processes.
This is an exciting time to join a company that is preparing for approval and launch of its first product. As a key member of a small, highly motivated and experienced internal core team in a dynamic environment this is a great opportunity to deploy all your project management skills and grow your role alongside the success of company. Initially a 12 month contract, we expect this can convert to a permanent role which, for the right candidate, we offer a competitive salary, pension contribution, private healthcare and company share options.
Education and Experience:
Essential
* Educated to at least degree level in a technical discipline (scientific / engineering / computing /maths).
* Minimum 5 years working on the design, development, or life cycle management of medical devices.
* Knowledge of appropriate quality and regulatory requirements in Europe and the USA, especially ISO 13485, ISO 14971, ISO, 21CFR Part 820.
* Experience working with medical device regulatory requirements, design control, change control, and risk management.
* Experience of 510(k) submissions.
* Skilled at project planning, critical path analysis and budget planning / forecasting
Desirable
* Knowledge and experience of devices for medical imaging, ideally gamma, SPECT or PET
* Understanding of software development process
* Experience of Human Factors / Usability Engineering
* Experience managing external partner companies