Jeannie Cecka
Principal Consultant, Medical Devices at Cecka Consulting Group
- Role
- Clinical and Regulatory Consultant, Glaucoma Surgical Devices at Santen
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Jeannie Cecka
Cecka Consulting Group partners with innovative medical device and biotech startups to define and navigate the regulatory pathway to market. With deep FDA and clinical experience, we provide practical, hands-on, and strategic support for FDA meetings, submissions, clinical development, and medical writing. A particular strength of our work is helping companies developing novel or first-of-kind technologies that may require charting new regulatory pathways, including De Novo classifications. Our collaborative, real-world approach ensures each client receives tailored guidance and expert representation throughout, from early product development through successful market approval.With decades of clinical and regulatory experience, Cecka Consulting Group has represented companies across nearly all major Class I, II, and medical device categories, including In Vitro Diagnostics (IVD), Cardiology and Cardiovascular Surgery, Cosmetic and Plastic Surgery, Dentistry, ENT, Gastroenterology, Gynecology, Neurology and Neurosurgery, Ophthalmic/Optical, and Orthopedics.We typically begin working with clients early in the product development process, helping to establish a clear regulatory strategy and roadmap. Our approach combines regulatory insight with strong project management skills to keep programs on schedule and aligned with FDA expectations, guiding teams through both familiar and uncharted territory.
Experience
Clinical and Regulatory Consultant, Glaucoma Surgical Devices
Jan 2015 — Present · Emeryville, CA, US
Education
Pepperdine Graziadio Business School
Master of Business Administration - MBA
UC Irvine
Bachelor of Science, Biological Sciences
Skills
- Clinical Trials
- Ophthalmology
- Cross-Functional Team Leadership
- Regulatory Submissions
- Strategy
- Medical Devices
- Clinical Research
- Quality System
- Pharmaceutical Industry
- Fda
- Regulatory Affairs
- Product Launch
- Surgery
- Project Management
- Life Sciences
- Design Control
- Biotechnology
- Iso 13485
- Start-Ups
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