Nancy Giezen
About Nancy Giezen
Nancy Giezen serves as the Manager of Regulatory Affairs at Conformis, where she has worked since 2019. With over 25 years of experience in regulatory affairs and nuclear medicine technology, she has held various roles in notable organizations including K2M and Cedars-Sinai.
Current Role at ConforMIS
Nancy Giezen serves as the Manager of Regulatory Affairs at ConforMIS, a position she has held since 2019. In this role, she focuses on process improvement and engineering/manufacturing change reviews. Her responsibilities include overseeing the development and review processes for submissions in both the United States and international markets. Giezen's expertise in regulatory affairs contributes to the company's compliance and operational efficiency.
Previous Experience at K2M
Before joining ConforMIS, Nancy Giezen worked at K2M as the Manager of Regulatory Affairs from 2007 to 2019. During her 12 years at K2M in Leesburg, VA, she played a significant role in managing regulatory submissions and ensuring compliance with industry standards. Her tenure at K2M provided her with extensive experience in the regulatory landscape of the medical device industry.
Consulting Experience
Nancy Giezen has a background in consulting, having worked at GIEZEN INC from 1996 to 1998 and at Quintiles from 1998 to 2001. Her consulting roles allowed her to develop a diverse skill set in regulatory affairs and compliance. This experience has equipped her with the ability to navigate complex regulatory environments effectively.
Educational Background
Nancy Giezen earned a Bachelor of Science degree in Nuclear Medicine Technology from the University of Buffalo. This educational foundation provided her with a strong understanding of medical technology, which she has applied throughout her career in regulatory affairs and compliance.
Expertise in Regulatory Affairs
Nancy Giezen possesses expertise in Unique Device Identification (UDI) systems, including GS1 and HIBCC standards, as well as Corrective and Preventive Action (CAPA) resolution. Her knowledge in these areas enhances her ability to manage regulatory processes and ensure compliance with applicable regulations.