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Maria Elena Insausti is a seasoned professional in Quality Assurance and Regulatory Affairs, currently serving as the Director at Beckman Coulter Diagnostics since August 2010. In this role, Maria Elena leads various functions including Quality Systems, Internal Audits, Process and Product Validation, and Risk Management across Europe, LATAM, METAM, CIS, and EE. Previously, Maria Elena held positions focused on Design and Process Validation, Product Safety Risk Management, and Commercial Quality Assurance for different regions. Maria Elena's academic qualifications include multiple degrees in Biological and Biomedical Sciences, and a Master of Science in Medical Technology from Mount Sinai School of Medical Technology.