Maria is a focused, driven, and passionate regulatory specialist with nearly 10 years of experience in medical device product development. She brings great depth of knowledge to the lean RAQA team, having earned a degree in biomedical engineering and a Master of Applied Science as well as her RAC certification.
Maria has played a strategic role in developing the market entry and compliance strategies of medical devices in various international markets. She has experience with a variety of international regulations, including Europe’s Medical Device Regulation (MDR), Australia’s Therapeutic Goods Administration (TGA), Health Canada, FDA, and others.
Her specialties include regulatory strategy and submissions, technical file development, Unique Device Identification (UDI) implementation and labeling design and review.
When not elbow-deep in international regulatory strategy, Maria is a passionate snowboarder and can often be found rocketing down a snowy mountain.
Fun fact: Kia Ora, I’m a French Canadian of German descent, living in New Zealand. Au plaisir!