Regulatory Affairs Manager
GE Healthcare Madison WI USA (Madison, WI)
In 1997, Nicole graduated with a Bachelor of Electrical Engineering from Ecole Polytechnique de Montréal. She began her professional career in quality assurance and regulatory affairs with a small medical device manufacturer where she discovered a passion for Regulatory Affairs. At the beginning of her career, Nicole joined RAPS and obtained her US RAC certification. She is currently part of the GE Healthcare (GEHC) One RA team for over 12 years.
Nicole cumulated 22 years managing the global registration of multiple classes of medical devices for different size manufacturers, developing robust global regulatory strategies to enable each product to reached their identified target markets in the shortest amount of time. The scope of her experience includes computer-assisted surgery system, ventricular assistant devices, EEG, ultrasound system, x-ray equipment, bone densitometers, and mammography systems.
Nicole is passionate about mentoring the next generation of regulatory professionals and takes pride in sharing her knowledge with her RAPS peers. Nicole is a recognized lecturer for RAPS and other organizations. Since 2014, Nicole is the faculty chair and presenter at the Preconference Workshop: Regulatory Strategy Forum for Medical Devices 2-day Workshop. She is also an adjunct Professor at Northeastern University teaching Regulatory Affairs Master's Program.
Nicole is a licensed Professional Engineer in the province of Ontario, Canada.
In 2016, Nicole was recognized as a Fellow of FRAPS for her contributions to the regulatory profession.
Saturday, September 21
9:00 AM – 5:00 PM
Sunday, September 22
8:00 AM – 4:00 PM
Tuesday, September 24
9:45 AM – 10:15 AM