Ms. George is a clinical and
regulatory affairs professional with a 20+ year career in the
medical products industry, with both large corporations and
start-up ventures. She combines expertise in clinical
practices, quality systems and regulatory affairs with project
management skills in order to meet business goals. Previously
the vice president of clinical, regulatory and quality systems
at a medical device incubator, and with a top tier clinical diagnostic company, she has established Quality Systems compliant with GMPs (Quality System Regulation); negotiated contract
agreements with clinical investigators; designed clinical
study protocols. In addition, Carolyn has authored CRF and IC documents; written
submissions to IRBs and Ethics Boards; conducted site
selection, qualification and monitoring of clinical studies;
developed regulatory strategies, negotiated with FDA on novel
products and submitted 510(k)s; as well as conducted the
regulatory aspects of due diligence on potential acquisitions.
Recent projects include clinical study management and IDE and
NDA submissions to CBER.
Ms. George received her BS
from the University of Cincinnati and her MS from Georgia
State University. She is qualified as a medical technologist [MT
(ASCP)] and has obtained RAC certification through RAPS
(Regulatory Affairs Professionals Society).
