Regulatory Affairs, Medical Devices, Medical Device, Regulatory Affairs Specialist, Bedford, Bedfordshire.
This company specialises in developing, manufacturing and supplying medical diagnostic products for the healthcare industry. As a market leading organisation they are now rapidly expanding and have a position available for a Regulatory Affairs Specialist to join their team in Bedford, Bedfordshire
As the Regulatory Affairs Specialist you will be responsible for providing regulatory support for the international distribution of the Diagnostic products.
Duties within this role will include:
*Processing regulatory enquiries from distribution companies and providing responses as required, including the acquisition of Certificates of Free Sale, and other legalised documents as required
*Preparing and maintaining marketing authorisation applications on a worldwide basis
*Maintaining the notifications to the EU Competent Authorities for CE marked products under (98/79/EC) and (93/42/EC) medical device directive
*Making and maintaining the required establishment registration and list applications to US FDA
*Reviewing all associated documentation
The suitable candidate will ideally be educated to a Degree level (or equivalent) within a Scientific Discipline and have previous experience of working in a Regulatory Affairs position within a medical device organisation. A strong understanding of ISO 13485, GMP and FDA standards is essential for this role.
The successful candidate will receive a competitive salary and full benefits package plus a fantastic work environment.
