Description
The Senior Project Engineer will work on UL’s Medical Regulatory Team, supporting and eventually leading audits of medical-device quality management systems and technical audits under programs such as ISO13485, MDSAP, UKCA, CE, and the MDR/IVDR. Responsibilities include contract review, audit reporting, corrective and preventive action analysis, competent authority support, customer guidance, training, and development of UL requirements. The role requires at least a degree in a relevant life-science or biomedical field, four years of healthcare-product experience including two years in quality management, knowledge of medical-device legislation and standards, auditing qualifications, and 50% to 75% national or international travel.
