Overview

Reference Number: JO-2103-465414
Regulatory Affairs Manager
Rate: £65,000 – 80,000
Job Type: Permanent
Location: Central London / West End

Job Title: Regulatory Affairs Manager

Location: Oxford, Reading, London, Home-based

Salary: £65,000 – £80,000 (negotiable DOE)

My client is a specialist biotech within the infectious disease space who are now looking for a Regulatory Affairs Manager who can support with a global roll out of there pioneering COVID Testing technology.

This role requires a candidate with a broad regulatory background within medical devices who will be able to lead on submissions, registration, health authority interactions as well as inputting into product development.

Role:

  • Responsibility for preparation and submissions of regulatory applications and registrations
  • Review of promotional material
  • Point of contact for competent authorities (UKAS, MHRA, EMA)
  • Work across both Regulatory and Quality functions
  • License maintenance

Experience:

  • 4 plus years within regulatory affairs
  • Broad experience with experience in at least one of the following: CE Marketing, UKAS, MHRA/EMA/FDA compliance, MDR compliance, IVDR compliance, CER
  • Able to work in a past paced environment

This is an urgent hire for the business so if you are interested please apply with your updated CV and I will be in touch ASAP to discuss further.