QMS Audit Readiness Lead for Medical Devices

Katalyst CRO is seeking a QMS Consultant to plan, scope, and lead mock audits ensuring readiness for a BSI notified body audit. You will evaluate the QMS against ISO 13485:2016 and EU MDR 2017/745, ensuring risk-based compliance and effective stakeholder communication. Role requires in-depth knowledge of medical device QMS, effective reporting, and strong cooperation with leadership to address gaps before a live audit.