Audrey Lucas

Audrey is a distinguished Quality and Regulatory professional whose career has been dedicated to advancing excellence, compliance, and patient safety within the medical device industry. With extensive experience navigating complex global regulatory and quality-system requirements, she has established herself as a trusted leader in the development, implementation, and continual improvement of medical device quality management systems. Throughout her career, Audrey has worked at the intersection of Quality, Regulatory Affairs, and operational excellence, supporting organizations in meeting rigorous international and regulatory expectations. Her expertise encompasses ISO 13485:2016, EU MDR 2017/745, FDA quality-system requirements and QMSR, MDSAP, UDI, labeling and traceability, supplier controls, complaint handling, vigilance, post-market surveillance, risk management, internal auditing, CAPA, document and change control, and management review. Her professional experience has also extended into auditing and objective assessment of quality systems, including her pursuit of opportunities as a medical device auditor. This reflects her commitment to using her knowledge and experience not only within individual organizations, but also to contribute more broadly to the advancement of quality and regulatory excellence throughout the medical device industry.