Regulatory Affairs Manager
- Experience Level
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.
- 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
- 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.