Senior Regulatory Affairs Specialist

Overview

Reference Number: JO-2105-468483
Senior Regulatory Affairs Specialist
Rate: £50,000 – 60,000
Job Type: Permanent
Location: Oxford

Job Title: Senior Regulatory Affairs Specialist

Location: Oxford

Salary: 50,000 – 60,000

Job Reference: JO-2105-468483

CPL are now working with a global leader within the Medical Device field who are looking to grow the team in Oxford with the hire of two Senior Regulatory Affairs Specialists. This is an exciting opportunity for candidates with a strong medical device or IVD background who are looking for a global role offering clear career development into a management position.

In this role you will work as part of a global team focused on changing regulations across EU, Middle East, Africa and Pakistan with responsibility for maintenance of technical files to EU MDR and IVDR.

Responsibility:

-Create, modify and maintain Technical Documentation demonstrating compliance to regulatory requirements within the EMEAP region

-Implement regulatory deliverables to support completion of business transitional activities related to the EU Medical Devices Regulation (MDR) and IVD Regulation (IVDR

-Support the Regulatory Affairs Manager in external interface activities with regulators, Notified Bodies and Trade Associations.

-Provide regulatory subject matter expertise to support business activities as required.

Experience:

-3 years plus Regulatory Affairs experience within the Medical device/IVD sector

-Strong understanding of MDR and IVDR

-Experience working in a global role desirable

-Technical background within Medical devices