Svetlana Bykanova

Chief Quality Officer at HOYA Vision Care

Speaker

Svetlana Bykanova is the Chief Quality Officer at HOYA Vision Care, with global responsibility for defining, maintaining, and overseeing the implementation of Quality and Regulatory Compliance strategies across the company’s manufacturing sites, functions, and regions worldwide.

With over 28 years of experience in the pharmaceutical and medical device industries, Svetlana has held progressively senior leadership roles spanning Quality, R&D, Regulatory Affairs, and Manufacturing. Among her key achievements are the implementation of the MDSAP program across more than 30 sites, the execution of EU MDR transition programs, and the successful EU MDR certification of medical devices of various risk classes in several organizations.

Svetlana brings extensive hands-on experience working with Notified Bodies and regulatory authorities globally, including TÜV SÜD, BSI, DQS, TÜV Rheinland, and multiple competent authorities worldwide.