Regulatory Affairs Senior Specialist - Medical Devices - Leeds
Are you a QA/RA professional looking for that next step? Does working for a small innovative company excite you more than a global giant? If so, give me a call ASAP.
A small but well-established Medical Device company is looking for a Regulatory Affairs Specialist/Manager to join their QA/RA department reporting into the Managing Director. It is a vital role for the company as you ensure the company is adhering to all relevant regulations. This will involve developing compliance strategies, completing and submitting documentation, working with international distributers and being the subject matter expert on MDR and UKCA regulations for Class III products.
Ideal experience and skills:
* A Bachelor's degree or higher in a life science discipline
* 3+ years' experience within Medical Device Quality Assurance
* Strong understanding and experience of MDR and Class III products
* Experience with clinical evaluation reports (CER) and post-market surveillance (PMS)
* Strong leadership skills and ability to own the MDR regulation compliance
* Networking ability, both internally and externally
To find out more information please contact Alex Eager on the following details. (url removed) (phone number removed)