Partner-Regulatory Affairs
SoftwareCPR
Ottawa, Ontario, Canada
Ginny is a regulatory affairs professional based in Ottawa, Canada, specializing in software-based medical products for over a decade. She has experience working with medical devices, pharmaceuticals and biotechnology, and she has developed regulatory strategies for a variety of SiMD/SaMD and AI/ML-based products throughout her career at start-ups, mid-size companies and global enterprises. She has worked on US and Canadian regulatory submissions and she has supported a variety of global submissions. In addition, she also has experience in quality assurance and software validation.
Ginny is a consulting partner and instructor at SoftwareCPR and also serves on the RAPS Ontario Chapter leadership team. She has previously served as a committee member for the Canadian Association of Professionals in Regulatory Affairs (CAPRA). Ginny obtained a BSc in Biochemistry from Concordia University, Montreal and an MS in Regulatory Science from Johns Hopkins University.
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Canadian Regulatory Framework for Software-based Medical Devices and Emerging Technologies
Thursday, March 7, 2024
10:30 AM – 11:30 AM East Coast USA Time