Nora York
About Nora York
Nora York Title: Vice President Regulatory Affairs and Quality Assurance
Nora York holds the position of Vice President of Regulatory Affairs and Quality Assurance. With an extensive career spanning over 35 years, Nora has amassed a wealth of experience in the regulatory field. Her role involves overseeing regulatory compliance and ensuring that quality standards are met across various medical device companies. She has a robust background in designing and implementing regulatory strategies, both domestically and internationally.
Nora York Education and Expertise
Nora York earned a Bachelor of Science in Biology from the University of Texas. Her educational foundation in biology has been instrumental in her ability to navigate the complex landscape of regulatory affairs. Over her career, she has specialized in regulatory due diligence, policy development, design control, and risk management oversight. Her expertise extends to handling regulatory submissions and ensuring compliance with US FDA and international standards.
Nora York Background at the US Food and Drug Administration
Nora York began her career at the US Food and Drug Administration (FDA), where she performed research and conducted post-market surveillance inspections and investigations of pharmaceutical and medical device firms. This foundational experience provided her with a solid understanding of regulatory compliance from a government perspective. Her work at the FDA involved thorough inspections and detailed evaluations to ensure that products met safety and efficacy standards.
Nora York Regulatory Services as an Independent Consultant
As an Independent Consultant, Nora York has offered a range of regulatory services, including submission strategy, review of advertising and promotion materials, and providing advice on FDA regulatory matters. Her consultancy work has been invaluable in helping medical device companies navigate the regulatory landscape. She has consulted for in vitro diagnostic, orthopedic, ambulatory infusion pump, ophthalmic, and cardiovascular Class II and Class III medical device companies.
Achievements of Nora York in Regulatory Affairs
Nora York has led several significant achievements in her career. Notably, she spearheaded the development and ISO 13485 QMS Certification for Canary Medical. Additionally, she led the efforts to achieve three Breakthrough Device designations and played a crucial role in obtaining commercial market authorization for the first implantable orthopedic SMART device, Canturio tibial extension. Her leadership and expertise have been instrumental in driving these key regulatory milestones.