Regulatory Affairs Senior Manager, Medical Devices - West of London

Turner Regulatory Recruitment ltd
£60,000 to £70,000, car allowance, bonus/benefits
17 Oct 2016
16 Nov 2016
Contract Type
Regulatory Affairs Senior Manager - Medical Devices for a top Biopharma!! This is an excellent role for a Regulatory Affairs professional within Medical Devices. Class III Medical Device experience essential, as is CE Marking. This role would suit a Regulatory Manager or Project Manager ready to take a step-up, as effectively this role is No. 2 in the Department. Pan European experience is required; other International territories would be an advantage.

Working for a Top Biopharma Company, you will be concentrating on Class II and III Medical Device Products, although Class Iis also involved. CE Marking and good working knowledge of the European Medical Device Directive are also essential. Development andmainly Life-cycle maintenance activity. You will deputise for the Associate Director, Medical Devices, when required. You will be in charge of a diverse portfolio of Products across a number of Therapeutic Areas. Project Leadership. Subject matter expertise. Formulation of robust Regulatory Strategies. Close liaison with the USA Office.

The role requires an individual who is adept in multi-tasking, and has excellent influencing and negotiating skills. In addition, you will possess the ability to analyse and interpret complex issues and develop effective strategies in a multi-matrix environment. Travel to the USA is required. Leading audits and inspections for the EU.

Candidate can come from a Medical Devices or In Vitro Diagnostics (IVD)background.

If you are interested in this, or any other Regulatory Affairs opportunity, please click apply now or contact Julian Turner at Turner Regulatory Recruitment