Kristen Kolegraff

Kristen Kolegraff, RAC, is an experienced Regulatory Affairs Manager currently at Ro, overseeing federal and state regulatory activities for medical devices, IVDs, and compounded products since August 2023. Prior to this role, Kristen served as Regulatory Affairs Manager at Cerus, where responsibilities included coordinating submissions, ensuring compliance with regulations, and maintaining regulatory filings. At OriGen Biomedical, Kristen developed global regulatory strategies and executed submissions, supporting product approvals and compliance. Previous positions included Senior QA/RA Specialist and Regulatory Affairs Specialist at Apollo Endosurgery, where Kristen handled submissions across multiple regions, and Complaints Analyst at Allergan, focusing on regulatory compliance related to product complaints. Kristen holds a Bachelor of Science in Pharmaceutical Chemistry from the University of California, Davis.