Bachelors degree or higher in Life Sciences, Clinical Laboratory Science, Computer Science or a related field At least 5 years experience in a quality assurance and/or regulatory affairs role within a regulated life science, clinical services or medical device environment Strong knowledge of US laboratory regulations, including CLIA 42 CFR 493 and CAP General Laboratory, Anatomic Pathology and proficiency testing requirements Working knowledge of FDA regulations applicable to clinical digital pathology, including 21 CFR 820 Excellent communication, collaboration and stakeholder management skills, including technical report writing Strong analytical and problem-solving skills, with the ability to work independently and manage multiple priorities and deadlines. Provide QA input across document reviews, supplier management, information security and data privacy processes Support client audits of clinical processes and coordinate post-audit activities, working closely with client quality teams on training, audit coordination and client evaluation documents Provide routine quality metrics to management for KPI monitoring and trend analysis Support the laboratory safety programme Drive continuous improvement, collaborating with cross-functional teams to identify and resolve quality issues and implement process improvements in line with best practice, including CAP, CLIA and HIPAA.