Primary Job Title Quality & Regulatory Affairs Manager Primary Organization
CellAegis Devices
Location Toronto, Ontario, Canada Regions Great Lakes Gender Female
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Michaela Shaw is Quality & Regulatory Affairs Manager at CellAegis Devices.
Ms. Shaw brings over 10 years experience within the medical device industry where she has focused on leading innovative, start-up medical device firms through the maze of the quality assurance and regulatory requirements to become successful and viable commercial
enterprises.
Ms. Shaw has expertise helping companies certify their Quality Management Systems to ISO 13485 and obtain Health Canada, European (CE Mark), Australian and FDA market approvals. Ms. Shaw understands the unique needs of innovative, technology-driven businesses and focuses on developing quality and regulatory strategies that are flexible enough to allow the creative innovations to thrive, while still focusing on the critical medical device regulatory priorities of safety and efficacy.


