Mrs. Collasius has served as OpGen’s department head of Quality Assurance and Regulatory affairs since 2017 and is responsible for the establishment and monitoring of good manufacturing practice programs compliant with FDA regulations, the development of regulatory strategies for legacy products and products in development, and the compilation of premarketing submissions to the FDA and international authorities. She is an established leader in the life science industry with extensive experience in quality and regulatory compliance for pharmaceutics, biopharmaceutics, and medical devices.
Mrs. Collasius holds a B.Sc. in Biology from Worcester State University and an M.Sc. in Regulatory Affairs from Northeastern University.