R and D Project Manager - Respiratory and Neo Natal Products
Salary: ~£45,000 basic plus pension plus exc hols
Location: Leicestershire
This is genuinely a SUPERB opportunity for an R and D Project Manager to join an entrepreneurial medical devices company - this company has grown year on year for the past 8 years.
The company specialises in respiratory and neo natal devices and this will be your opportunity to MAKE YOUR MARK as the company's first R and D manager. It is important that you have an electronics - mechanical background and demonstrable R and D experience gained from within the healthcare market place specifically medical devices.
You will be very familiar with the workings of the MHRA in London and have experience of Regulatory Affairs. You will work towards the medical devices directive 13485 and compile the 510Ks / CE marketing documents for the company.
Part of your remit will be managing the contractors and sub contractors on all R and D matters - these being predominantly in the UK and rest of Europe.
On joining you will be responsible for completing a new product launch and design project associated with the neo natal market place - future opportunities will invariably lead you to managing a team within the R and D department and Regulatory Affairs department and may well involve you with International Travel.
Other aspects of this role will include Managing and controlling all aspects of R and D projects - identifying and acting on business development opportunities.
You will manage and run R and D projects - through from conception to market launch.
You will be responsible for managing the Regulatory Affairs including liaison with competent authorities, notified bodies and consultant surgeons. You will manage the submissions for regulatory approvals (FDA 510K, Shonin, CE Marking). You will have the opportunity to support the business Quality policy and objectives. On the regulatory side of things you will be managing the day to day compliance with ISO 13485/CAMDCAS/21CFR part 820.
You will select and manage sub contractors to fulfill various functions needed to realise R and D projects.
You'll see that his is a fantastic opportunity to really drive this role and lead it.
If you are looking to really take the bull by the horns so to speak and join an exciting and forward thinking privately owned company - one that has no bank loans and is cash rich then this could be the role for you.
This is the first position within the company of this type so you really will be able to make the position what you want to.
Contact including your CV and quoting reference randd0509 or telephone us on 0845 603 1807.