Senior Regulatory Specialist - 12 month Fixed Term Contract
As Senior Regulatory Specialist will provide support to the QARA team ensuring that Quanta's CE , FDA and other regulatory status is maintained. As Senior 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.
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.
- Previous working experience in a regulatory affairs department of a medical devices business, preferably with the various pathways for FDA submission, specifically that of 510(k).
- Experience with the construction and maintenance of a Technical File as required for CE, and with implementation of the MDR (and UKCA – desirable).