Regulatory Affairs Specialist, Medical Devices, Medical Device, Bedford, Regulatory Affairs Specialist
This Bedford based organisation has been established for a number of years and is a specialist in developing, manufacturing and supplying Medical Diagnostic products for the healthcare industry. As a market leader they now have a position available for a 12 months contract Regulatory Affairs specialist to join their team.
As the Regulatory Affairs Specialist you will provide regulatory support for all manufactured products.
Other duties within this role will include:
-Maintaining product specific technical files
-Preparing and maintaining marketing authorisation applications
-Processing regulatory enquires and providing responses
-Making the required notifications to EU competent authorities regarding CE Marked products under the medical device directives (98/79/EC) and (93/42/EC)
-Evaluating the regulatory implications of changes to products in routine manufacture
The suitable candidate will ideally be educated to a Degree level (or equivalent) in a chemical / biological science discipline. Previous experience of working in a Regulatory Affairs environment within the medical device industry is essential for this role with strong knowledge in CE Marking and FDA standards.
This is a fantastic opportunity to work for a specialised, market leading company within a friendly environment.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
