Carol Ryerson, Ph.D. has joined RCRI in the role of Senior Principal Advisor, Regulatory Affairs. Ryerson specializes in regulatory strategy, clinical affairs, and research and development for the IVD and medical device industry.
In her 30 years of experience in the medical device industry, Ryerson has developed domestic and international regulatory strategies, drafted submissions, and negotiated their approval by FDA and other regulatory agencies. Leveraging her years of R&D and product development experience, Carol has worked with teams at IVD and medical device companies during initial phases of product design to provide regulatory support and guidance, clinical study design, and/or labeling/advertising and promotion reviews. Carol has supported product registrations for clinical chemistry systems and reagents, coagulation systems and reagents, infectious disease IVDs, imaging devices in mammography, oncology, and general radiology.
Based in Boston, Massachusetts, Carol holds a Bachelor’s degree in Chemistry from the College of the Holy Cross, and a Ph. D. in Biochemistry from the Massachusetts Institute of Technology.
Carol’s experience enhances RCRI’s knowledge and experience base of IVD product development which includes regulatory strategy, study design and execution, statistical support, data analysis, reporting, and regulatory submissions across a wide range of applications, e.g., coagulation, hematology, cardiac, gastrointestinal, urology, pulmonary, women’s health.
Contact Carol at firstname.lastname@example.org