Job Description
Cure Talent are delighted to be partnered with a rapidly growing medical device company with a diverse portfolio spanning IV therapy, diabetes care, surgical, anaesthesia, sexual health and more. As the business continues to expand, we have an exciting opportunity for a Regulatory Affairs Specialist to join their dedicated Quality & Regulatory team.
This is a hybrid role with the expectation of being on site in Uxbridge once a week.
As the new Regulatory Affairs Specialist, you will play a vital role in supporting all Quality and Regulatory activities across the business. You will contribute to the development and maintenance of regulatory documentation, ensure compliance with global standards, and support smooth implementation of evolving regulations, while working closely with internal teams and external stakeholders.
Key Responsibilities
1. Support and maintain the company’s Quality Management System (QMS).
2. Write, review, and maintain technical files and other regulatory documentation (MDD, MDR, IVDR, UKCA, FDA, Procedure Packs).
3. Ensure compliance with UKCA, EU MDR, FDA and relevant ISO standards.
4. Manage document control, updating procedures and product fact sheets.
5. Support product development and UDI processes.
6. Coordinate and support internal and external audits.
7. Monitor...