Title:

Regulatory Affairs Manager

Location:

Bedfordshire

Salary:

GBP 40,000 to GBP 60,000 per year

Description:

This is an exciting opportunity with a world class manufacturing organisation. Specialising in supply medical deviceproducts to clients, they are looking to further expand their expertise at their site in Bedfordshire. Reporting to theVP Worldwide Quality & Regulatory Affairs, this is a pivotal role in the further growth of the business. Responsibilitiesinclude: Global strategy and content of all Regulatory submissions and registrations Develop a regulatory strategic plan for product category and be responsible for its implementation and documentationwithin the project plan Responsibility for the development of the strategic and tactical plan for DoA products which will lead to the mostexpedient method of approval for regulatory submissions Work closely with other functional leaders to identify and select well reocognised clinical investigationsCandidates: Degree qualified in a Life Science discipline coupled with 10 years experience of Regulatory / Clinical Affairs for theUSA and international markets A comprehensive working knowledge of FDA regulations along with a proven track record of submissions and approvals withregulatory agencies Excellent communication skills and will be clear and concise in all forms of communication, as well as be able toarticulate clear requirements and expectations for the Regulatory Affairs function