Contract SAP Regulatory Affair Specialist, Medical Devices, Medical Device, Bedford, SAP Regulatory Affairs Specialist
This reputable organisation is a specialist in developing and supplying medical diagnostic products for the healthcare industry. They now have an exciting position available for a Regulatory Affairs Specialist to join their team in Bedford on a 12 months contract.
As the SAP Regulatory Affairs Specialist you will be responsible for implementing an SAP regulatory control mechanism to ensure compliant shipments for all products distributed.
Other duties within this varied role will include:
-Compiling a database of all products for uploading into SAP
-Liaising with other sites to ascertain where products are currently registered and ensuring all the necessary approvals are held on file
-Preparing procedures to control the operation of the new SAP Regulatory Control System
-Ensuring that there is a procedure to address any future changes in the regulations or changes in product approval status
-Being responsible for implementing training in the new system in consultation with the QA Training Manager
The suitable candidate will ideally be educated to a Degree level (or equivalent) in a chemical / biological science discipline. Experience of working with medical devices to ISO, GMP and FDA standards is essential for this role. You will also have experience of working with regulatory agencies and processes in international markets with a proven track record of submissions and approvals.
This varied role will provide the successful applicant with a fantastic opportunity of working within a large market leading organisation where you can further develop and enhance your skills.
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.
