Christopher Kotsopulos – Consultant, Quality Systems and Regulatory Affairs

Chris K headshot

Christopher is a medical device industry expert with over 20 years of medical device industry experience. Christopher has been consulting to clients in the biomedical industry since 2012 and has developed a keen ability to distill complex systems into simple concepts. Throughout his career, he has worked for large, mid-size and start-up organizations, during which time he acquired comprehensive Quality Management and Regulatory Affairs experience. Christopher’s proven areas of strength include Regulatory Affairs, Quality Management, Quality Assurance, Management Controls, CAPA, Training, Design Assurance and Controls, Change Management, Validation, Risk Management, Audit Management, Production and Process Controls, Sustaining Engineering, Quality Control, and Complaint Management. He has a Master of Science in Medical Device, Pharmaceuticals and Biologics from Northeastern University in Boston and a B.A. degree from Rutgers College.

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