Regulatory Affairs and Quality Assurance Assistant - Cambridge

Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge Due to the growth of a medical devices company based in Cambridge, there is need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the company''s Quality Assurance and Regulatory Affairs Manager. The team provide quality assurance and regulatory affairs advise on the creation of new products and the improvement of existing technologies. It would be highly advantageous if you have knowledge of design processes, but it''s not essential. This team does not just fill out quality assurance and regulatory documents; this is a team where they will be very involved with the RandD team, providing vital advice on the creation of medical devices, and ensuring the team operates within the FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards. It would be ideal if you have both quality assurance and regulatory affairs knowledge. However, people have moved into this role from either regulatory affairs or quality assurance background, but with a general knowledge in the other side. It is essential that you have medical devices knowledge, especially ISO 13485 and FDA 510k knowledge. Although writing submissions will not be a major part of your role, you will relay information to the teams responsible for this, so ideally you will have done this in the past or at least assisted. Ideally, you will have QMS experience. If you do have this knowledge, I would advise making it ..... full job details .....