3 jobs
Bluetree Cambridge £65,000 – £80,000 pa
Lead regulatory strategy for a cardiology device company expanding into the US, UK, EU and Middle East, owning FDA, CE and UKCA submissions from Class I to Class II/III. Drive an audit-ready QMS (ISO 13485, 21 CFR Part 820, ISO 14971) and advise senior leadership on regulation, quality and clinical governance, working directly with the FDA, MHRA and notified bodies.
NHS Professionals Worcestershire £20 pa
Perform biochemical analyses on patient samples using manual and automated techniques, maintain and QC point-of-care testing equipment, and authorise results for electronic reporting to wards. The role includes out-of-hours rota cover, giving technical advice to clinical staff, and supporting quality management within a hospital Clinical Biochemistry service.
University of Leeds Leeds £41,064 – £48,822 pa
Develop a clinically deployable assay for therapeutic drug monitoring of the immunosuppressant tacrolimus, building on a recently created rapid, accurate and low-cost measurement method. Work within a multidisciplinary team focused on in vitro diagnostics assays and devices that improve dosing and patient outcomes, replacing slow mass spectroscopy workflows.
SRG Lancashire
Maintains and improves a medical device Quality Management System in line with ISO 13485 and FDA QSR, leading non-conformance, deviation, complaint and CAPA investigations with root cause analysis. Supports internal, supplier and regulatory audits, risk management under ISO 14971, validation and design transfer, working with Manufacturing, R&D, Regulatory Affairs and Supply Chain.
