Christopher Mclean Email & Phone Number

An established leader in Regulatory Affairs and Quality Systems with a background in Product Development and Research in the field of Medical Devices. Team player with strong interpersonal skills. Results driven and detail oriented. Fluent in English and French.Key areas of expertise include:• Regulatory Affairs (RA) and Quality Assurance (QA) Systems• ISO 13485, FDA 21 CFR 820/803/806/7, EU MDD 93/42/EEC & MDR 2017/745, Health Canada Regulations, ISO 14971 • Product registrations: US 510(k), CE Marking, Health Canada licenses• Design Controls and Product Development, software lifecycle processes • Medical Device Reporting (MDRs) and Recalls• Product Sterilization, Sterile Package Validation

Listed skills include Medical Devices, Biomedical Engineering, Iso 13485, Quality System, and 16 others.