Description
You will be working closely with the Senior Management Team and Clinical Director based in Europe, you will be responsible for defining the clinical strategy to obtain CE and FDA clearance for the company's products.Working in a small, close-knit company you will have a broad remit - Attending trial-related meetings with various regulatory agencies, developing and maintaining the overall clinical programme budget, keep abreast of study results, evaluate protocol strategies, obtain post-market clearances and more.
In addition to clinical trial activities, you will also be identifying and working with Key Opinion Leaders (KOLs) to plan clinical programmes, resolve problems and ultimately help to convert prospects into customers - transitioning national sites into beta sites for initial post-market clearance.
Key Skills:
- Minimum 5 years experience of working in clinical operations in a medical device environment at a director level.
- Knowledge of medical devices
- Experience of clinical trials in EU
- Knowledge of Medical Devices Directive and other relevant legislation
- Experience working within and compliance to a ISO 13485 / FDA 21 CFR 820
- Proactive and self motivated
- Experience of applications of European CE Mark and US 510K approvals
- Understanding of relevant Standards including ISO 14155 (as well as SG5/N2R8), ISO 14971 & 10993
This is an excellent opportunity to work for a fast moving organisation, offering competitive hourly rates. If you are interested in this position and would like some more information please send an updated CV and call Hailey McDermott on .
Please do pass this opportunity onto anybody you know who may be interested as we do offer £250 referral vouchers.