Richard M. Stewart

WORK HISTORY

EDUCATION

ABOUT RICHARD M. STEWART

Serves as Chief Regulatory Affairs & Quality Officer for Digital Health, Precision Health, SaMD, medical devices, Ai-driven Medical Devices & CDx.+10 years Quality Systems & Regulatory Affairs Senior Executive Leadership experience and +25 years Life Sciences professional. Solutions-driven leader partnering regulatory affairs, quality, business development, clinical operations, digital health, and market access. Certified training and direct work experience in the following: FDA 21 CFR Parts 11, 50, 54, 56, 800, 820 to 1299 • ISO 13485 MDR/MDSAP/CMDCAS • ISO 14971 • ICH E6 GCP • HHS Title 45 CFR 46 • ISO 14155 • IEC 82304 • IEC 62304 • Canadian CMDR SOR/98-282 • BS EN 980:2008 CE Req. • 93/42/EEC- MDD to MDR 2017/745 • 98/79/EC IVDD • IRB, Investigators, & Sponsors • FDA & Notified Body Audits • Risk Management • Design & Process Controls: SAMD, AI/ML-enabled Medical Devices, IVDD & Clinical • CDRH and CBER Procedures • Lead Auditor Internal & Supplier Audit Inspections • RUO/IUO • International Registrations & Rqmts.• Facility/Equipment Qualification • Design Transfer • Process Validation • Software Validation • Software as a Medical Device • Test Method Development • LDT CLIA/CAP • Pre-Determined Change Control Plan Builds and Oversees global & FDA regulatory affairs teams and submissions: International Regulatory Registrations for +15 countries, FDA EUA, IDE, Pre-Sub, De Novo, Traditional 510(k), PMA, CDx, Technical Dossier, CE Marking and Product Registrations, CLIA Waiver/Amendments, Certificate to Foreign Government, and Note/Add-to-Files. Empowers teams, drives change to meet company milestones in compliant framework.