Carolyn is a regulatory and clinical consultant and leads CTM Medical Consulting. She has over 10 years of combined experience in regulatory, scientific, and medical writing, covering cardiology, diabetes, orthopedics, ophthalmology, molecular diagnostics and biologics.
Carolyn began her career as a research scientist in academia and the pharmaceutical and in-vitro diagnostic industries. She then transitioned to Regulatory Affairs while working at Medtronic in the Diabetes division. Later, at Edwards Lifesciences, she served as Manager of Scientific Communications in Clinical Affairs, responsible for global regulatory submissions for the Transcatheter Heart Valve business unit. She then became Director of Medical Writing at Network Partners, a management consulting firm, where she established the medical writing department that supported Fortune 500 companies, EU MDR and IVDR compliance.
Carolyn holds a BSc degree in Biological Sciences from UC Irvine and a Master’s degree in Molecular Biology from USC.