Director of Regulatory Affairs and Quality Assurance
Carolyn serves as the Director of both Regulatory Affairs and Quality Assurance for Kapstone Medical.
She has been in the Medical Device industry in a quality and regulatory function for the past 15 years, working for and with both large corporations, and start-up companies with a single employee.
The types of devices she has worked with has varied from In Vitro Diagnostic devices, to Orthopedics, Dental, Software, and Kitting, Packaging and Sterilization services. Carolyn has experience globally, with a focus on North America and Europe, in both the premarket and postmarket quality and regulatory functions, including premarket submissions (510(k) and CE Mark), as well as day-to-day operations in quality assurance and quality systems.
Originally from South Africa, Carolyn is now based out of Charlotte, NC.
She holds a BS in Biochemistry and Microbiology and an MS in Human Cell Biology from the University of Cape Town in South Africa, and an MS in Regulatory Affairs (International) from Northeastern University in Boston, MA. In addition, she holds a RAC (Regulatory Affairs Professional Society Certification) for the US.