John Simon

Biography

John began working with TEC Edmonton as an independent consultant in 2011. As a Regulatory Consultant, John is responsible for quality assurance and regulatory affairs. He helps companies obtain site licenses and product licenses in support of manufacturing and market authorization for Biologics, pharmaceuticals, medical devices, natural health products, and cosmetics. John has a Bachelor of Science from the University of Alberta, and is a senior member of the American Society for Quality. He is a Certified Quality Auditor (CQA), and has Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society, as well as RQAP-GLP certification through the Society of Quality Assurance. In his career, John has held a series of management positions in quality assurance and regulatory affairs and also works as a consultant. He has experience being directly involved in FDA and Health Canada Audits in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites, as well as experience with a number of submissions to Health Canada and the FDA. Outside of work, John is probably coaching minor hockey for his three kids. John began working with TEC Edmonton as an independent consultant in 2011. As a Regulatory Consultant, John is responsible for quality assurance and regulatory affairs. He helps companies obtain site licenses and product licenses in support of manufacturing and market authorization for Biologics, pharmaceuticals, medical devices, natural health products, and cosmetics. John has a Bachelor of Science from the University of Alberta, and is a senior member of the American Society for Quality. He is a Certified Quality Auditor (CQA), and has Regulatory Affairs Certification (RAC) through the Regulatory Affairs Professional Society, as well as RQAP-GLP certification through the Society of Quality Assurance. In his career, John has held a series of management positions in quality assurance and regulatory affairs and also works as a consultant. He has experience being directly involved in FDA and Health Canada Audits in the areas of Medical Device Manufacturing, Drug Manufacturing and Testing, Drug and Device Establishments and Clinical Trial sites, as well as experience with a number of submissions to Health Canada and the FDA. Outside of work, John is probably coaching minor hockey for his three kids.

Research Interest

Biologics, pharmaceuticals, medical devices, natural health products, and cosmetics.