As Regulatory Specialist will provide support to the QARA team ensuring that Quanta's CE status and Technical File is maintained. As Regulatory Specialist you’ll coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals and registrations, and compile and prepare materials for submission to regulatory agencies. The Regulatory Specialist will also provide support with the application for the FDA 510(k) process.
Quanta Dialysis Technologies is a pioneering medical device company based in Warwickshire. We are on a mission to become the world's leading provider of self-care solutions for haemodialysis patients, and we are only at the beginning of our story.
Quanta is focused on the commercialisation and ongoing development of SC+, an innovative cartridge-based haemodialysis system. SC+ is a high performance, compact haemodialysis system which is revolutionising this market sector.
As the preferred candidate for the role of Regulatory Specialist you’ll have:
- Experience with the various pathways for FDA submission, specifically that of 510(k) and the associated selection of predicate devices.
- Experience with medical devices (not necessarily haemodialysis) and the 510(k) process.
- Experience with the construction and maintenance of a Technical File as required for CE.
- Experience with the implementation of the MDR (UKCA also desirable).