James Gianoutsos, MBA

James Gianoutsos, MBA has worked in the medical technology industry since 2006. James began their career as a Quality Assurance Intern at Respironics in 2006, followed by roles as a Quality Assurance Analyst, Quality Systems Business Analyst, Senior Quality Assurance Analyst, and Senior Quality Assurance Engineer at Philips from 2007-2012. In 2012, they became Quality Assurance Systems Manager and Senior Quality Engineer at Cohera Medical, Inc. In 2015, they were Manager of Quality Assurance & Regulatory Affairs at Circadiance. In 2017, they were Director of Quality Assurance & Regulatory Affairs (QA/RA) at Carmell Therapeutics, Founder & Principal Consultant at Regality Consulting, LLC, and Founder & CEO at Rimsys Regulatory Management Software.

James Gianoutsos holds a Master of Business Administration (M.B.A.) from the University of Pittsburgh Katz Graduate School of Business, which they obtained in 2012 with a focus on Operations Management and Strategy. James also holds a Bachelor's Degree from Indiana University of Pennsylvania in Operations Management, which they obtained in 2006. James also holds a number of certifications from the American Society for Quality (ASQ), including Certified Quality Auditor (CQA) (2010), Certified Quality Process Analyst (CQPA), Certified Six Sigma Green Belt (CSSGB), Integrating Risk Management into the Quality System, Process Validation - Medical Devices, Quality System Requirements and Industry Practice, and Regulatory Affairs Certificate - Medical Devices from the Regulatory Affairs Professionals Society (RAPS).