Annette M. Zinn, M.P.H., Ph.D., J.D.

Dr. Zinn holds a Ph.D. in Management & Policy from the University of Texas, School of Public Health, a J.D. from the South Texas College of Law, and a M.P.H. from The University of Texas School of Public Health. She is a member of the American Bar Association (Section: Administrative Law), the Texas Bar Association (Sections: Administrative Law; Health Law), the United States District Court, Southern District of Texas, the Food and Drug Law Institute, Regulatory Affairs Professional Society and the American Public Health Association. In addition to her education and associations, Dr. Zinn has published and presented on topics including medical device advertising, quality, regulation and law.

Dr. Zinn has extensive experience interacting with FDA regarding a wide range of activities. As regulatory counsel for cardiac rhythm management and neuromodulation companies, she has developed strategies for regulatory submissions worldwide including clinical trials and marketing approvals. She has implemented these strategies and prepared regulatory submissions for FDA (two panel meetings) and other regulatory agencies to obtain marketing approvals for new indications (PMA), design changes, manufacturing changes, annual reports and post-approval studies. Dr. Zinn has been involved in many different aspects of FDA regulation including interfacing with reviewers to satisfy requirements, participated in FDA advisory panel meetings, assisting FDA with facility inspections, handling complaints from health care providers and patients, and conducting internal audits to ensure compliance with law and regulations.

In addition to Dr. Zinn's corporate experience, she has served as an adjunct faculty member at the University of Houston College Of Law where she was a co-instructor for the Food & Drug Law Course in the Master of Laws, LLM, program.

Copyright ©2010 Laughlin Engineering Firm, LLC All Rights Reserved