Regulatory Affairs Specialist, Medical Devices, Medical Device, Bedfordshire, Regulatory Affairs Specialist,
This rapidly expanding organisation specialises in developing, manufacturing and supplying fertility diagnostic products for the healthcare market. Although this company has not been established for long, they have already become a market leader within the medical device sector and are looking for a Regulatory Affairs Specialist to join the team in 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 Chemical/Biological discipline and have relevant experience of working within a Regulatory Affairs or Quality Assurance 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 whilst working in a supportive and friendly environment where hard work is always rewarded.
