Director of Regulatory Affairs and Quality Assurance
Carolyn has 15 year's experience in quality assurance and regulatory affairs in the Medical Device industry. She has worked 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 pre-market and post-market quality and regulatory functions, including pre-market submissions (510(k) and CE Mark), as well as day-to-day operations in quality assurance and quality systems.
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. Additionally, she holds a RAC (Regulatory Affairs Professional Society Certification) for the US.
