Stephen Smith

WORK HISTORY

EDUCATION

SKILLS

ABOUT STEPHEN SMITH

As a Fellow of both the CQI and TOPRA, I am a passionate Quality and Regulatory leader dedicated to bridging the gap between rigorous compliance and commercial success in the Medical Device industry. With a career spanning over 25 years, I have a proven track record of designing and implementing pragmatic Quality Management Systems that are both audit-ready and business-enabling, with a special focus on guiding start-ups through rapid growth.My expertise covers the entire product lifecycle across a diverse range of devices and IVDs. I have deep, hands-on experience with-Strategic Global Submissions: Leading successful approvals/clearances in the US (FDA), UK, EU (MDR/IVDR), Canada, Australia, and other key markets-End-to-End QMS Leadership: From establishing systems from the ground up to managing complex audits against ISO 13485, MDSAP, and FDA requirements-Technical Excellence: Driving robust processes for Risk Management (ISO 14971), Verification & Validation, Root Cause Analysis, and Post-Market Surveillance-Emerging Technologies: Applying AI and machine learning principles within a regulated medical device context.I am equally committed to shaping the future of our industry. I serve as a Module Lead and Lecturer for the TOPRA MSc in Regulatory Affairs, frequently present at international conferences, and actively mentor undergraduate and postgraduate students.