Nora York

Nora York is responsible for Regulatory Affairs and Quality Assurance activities.

Nora has over 35 years of regulatory affairs experience beginning at the US Food and Drug Administration, where she performed research, conducted post-market surveillance inspections and investigations of pharmaceutical and medical devices firms.

Since then, Nora has achieved experience in regulatory due diligence, submission strategy for both, US and international filings, policy development and implementation, design control and risk management oversight at in vitro diagnostic, orthopedic, ambulatory infusion pump, ophthalmic, and cardiovascular Class II and Class III medical devices companies in leadership and consultant roles. In Independent Consultant roles, she provided regulatory services for submission strategy, review of advertising and promotion, and advice to legal counsel on FDA regulatory matters. This experience has prepared her for her current role where she led the development and achievement of Canary Medical’s ISO 13485 QMS Certification, three (3) Breakthrough Device designations and commercial market authorization for the first implantable orthopedic SMART device, Canturio tibial extension.

Nora holds a Bachelor of Science in Biology from the University of Texas.