Regulatory Affairs Associate – Global Medical Devices Company – Remote – £negotiable
The Regulatory Affairs Associate is responsible for submitting and maintaining global regulatory approvals, to support regulatory submissions for new markets and maintaining registrations and licences in existing markets.
This is an exciting time to join an expanding, highly successful global medical devices company based at their site in Cheshire. They develop and manufacture their own products and have an excellent R&D capability ensuring they stay at the forefront of medical devices and associated technology.
- Global, leading medical devices company
- Manufacture and register a range of high-quality devices as well as many more in the pipeline
- At the forefront of medical devices, particularly within wound care
The Regulatory Affairs Associate will be responsible for;
- Submit and maintain global regulatory approvals, supporting regulatory submissions for new markets and maintaining registrations and licences in existing markets.
- Advising the business regarding any regulatory enquiries
- Coordinate the preparation, review and submit timely responses to requests for additional information from regulatory authorities on product registrations.
To apply for this role as a Regulatory Affairs Associate our client is hoping for someone with the following skills and experience;
- Good regulatory experience within medical devices (ideally up to class III)
- Good knowledge of MDD/MDR (desirable)
- Good knowledge of ISO 134585
- Ideally experienced in managing registrations in EMEA, LATAM & APAC (desirable not essential)
- Science based degree
What should you do next?
This Regulatory Affairs Associate role is one not to be missed; it encompasses the opportunity to work with new and exciting products within a company who are at the forefront of medical devices. To discuss further, please submit your current CV.
Unless otherwise stated, if applying for a job within the European Union, you must ensure that you are already authorised to work there.
Carrot Pharma Recruitment Ltd acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.