Christopher McLean
Senior Consultant at Lok North America Inc
Based in Montreal, Canada
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Seniority
Manager
Department
General Business & Management
Location
Montreal
Industry
Medical Equipment Manufacturing
Company size
12
Contact information
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c•••••••@lok-northamerica.com
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Background
About Christopher McLean
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
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