Jeannie Cecka

Ms. Cecka is ClearSight’s Director of Regulatory Affairs, bringing many years of experience in Ophthalmic device market approvals and clinical trials with her. She has been involved with taking products through US and European market approval processes for both large and small companies, including Abbott Medical Optics (AMO), Hoya Surgical, Allergan, Baxter, PowerVision, TrueVision, and Glaukos. These roles have spanned from Director of Clinical Affairs to Director of Regulatory and Quality Affairs.

She has overseen FDA clinical trials and marketing studies, developed clinical protocols in collaboration with regulatory bodies, interfaced with physicians, obtained IRB approvals, assembled and submitted IDEs, 510(k) s, PMAs, and Technical Files. She has deep experience in strategic planning, clinical data assessment, literature review, design control, labeling, and medical writing.