IEEE Senior Member,
IEEE Eta Kappa Nu Honor Society,
Mansfield Fellow

Carole chairs the First IEEE Baltimore Technical Colloquium and Professional Development Conference, 2024.  She is a long time IEEE member volunteer and served in leadership roles at the Section and Region levels, Women in Engineering, IEEE USA, Engineering in Medicine and Biology (EMB), and the Consumer Technology (CTSoc) societies. For many years, she chaired the EMB Standards Committee (SC) and currently is the Standards Representative to IEEE Standards Association (SA). She holds the position Member-at-large, CTSoc Blockchain SC and Vice-Chair, Metaverse SC. Carole is an Associate Editor of the IEEE Open Journal of Engineering in Medicine and Biology (OJEMB), a member of the IEEE 2621 Conformity Assessment Committee that developed the Medical Device Cybersecurity Certification program. She is active in IEEE SA Industry Connections (IC) and a member of the Neurotechnologies for Brain-Machine Interfacing (BMI) activity. The output of this activity is publication of Standards Roadmap: Neurotechnologies for Brain-Machine Interfacing (2020) and an article in OJEMB, “Standardization of Neurotechnology for Brain-Machine Interfacing: State of the Art and Recommendations” (2021). Ongoing is the Clinical Trial Technology Modernization Network IC activity.

Carole is Founder of C3-Carey Consultants, LLC, a medical devices consultancy that provides regulatory intelligence and strategy to assist regulated industry bring innovative, safe and effective medical products to market. Earlier, she worked at US FDA Medical Device Program, Center for Devices and Radiological Health (CDRH) as peer-reviewed Expert Regulatory Review Scientist. As a member of FDA’s AED (automated external defibrillator) Task Force, she made significant contributions to the AED Early Defibrillation and Public Access Program. As a Mansfield Fellow, Carole was a visiting regulatory scientist in Japan’s Ministry of Health, and the Pharmaceutical and Medical Devices Agency. Post fellowship, she served as International Advisor and Director of International Staff at CDRH. She has authored several book chapters on medical device regulations.

She has a Bachelor in Electrical Engineering from Johns Hopkins University and Masters of Engineering Science with concentrations in Computer Engineering from Loyola University, Maryland