Regulatory Affairs Specialist, Medical Devices, Medical Device, Bedfordshire, Regulatory Affairs Specialist
This globally recognised organisation specialises in developing and manufacturing medical diagnostic products. Due to the launch of new products they now have an exciting opportunity for a Regulatory Affairs Specialist to work on a fixed term contract for 6 months at the Bedford site.
As the Regulatory Affairs Specialist you will be responsible for providing regulatory support for the international distribution of the products.
Within this key role you will be responsible for:
-Preparing and maintaining marketing authorization applications on a worldwide basis
-Processing regulatory enquiries
-Making and maintaining the required notifications to EU competent authorities for CE marked products
-Making and maintaining the required establishment registration and listing applications to US FDA
-Providing reviews and approvals of product labeling and promotional materials
The suitable candidate will ideally be educated to a Degree level (or equivalent) within an engineering discipline. Experience of working to ISO 13485, FDA and GMP standards is required for this role. The successful applicant must have previous experience of working within a regulatory role in the medical devices market.
The suitable candidate will ideally be educated to a Degree Level (or equivalent) within an Engineering discipline. Experience of leading a regulatory team within a medical device organisation is essential for this role. A strong background in working to ISO 13485, FDA and GMP standards is essential for this role.
The successful candidate will have the opportunity to work for a growing market leader, where you can further develop and enhance your skills.
Keywords – Regulatory Affairs Manager, Regulatory Affairs, Medical Devices, Medical Device, Bedford, Bedfordshire, Ra Manager, RA Specialist, Regulatory Affairs Specialist
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.
