Han Si

Han Si is a skilled Regulatory Affairs and Quality Assurance Specialist currently employed at Genabio Diagnostics since February 2024, where responsibilities include assisting in the successful submission of 510k and CLIA Waivers and engaging in FDA communication for technical inquiries. Prior experience includes a Capstone Project at BLA Regulatory focused on FDA fast-track drug approval strategies, a Quality Regulatory Compliance Intern role at AG Mednet overseeing quality management systems, and several Quality Assurance positions at Melville Candy Co and Belfonte Dairy, where Han Si developed quality systems and compliance programs. Educational qualifications include a Master of Science in Regulatory Affairs from Northeastern University and a Bachelor of Science in Dairy Manufacturing from South Dakota State University.