Yulia Nikova

Yulia Nikova is a Regulatory Affairs Manager at Ken Block Consulting, specializing in various medical technologies and regulatory pathways for devices. With expertise in high-speed surgical instruments, drug delivery, and AI diagnostic technologies, Yulia leads client meetings and strategizes FDA submissions, including 510(k) and De Novo applications. Previous roles include Regulatory Project Manager and Regulatory Affairs Specialist, where Yulia managed regulatory documentation and product lifecycle planning. Experience spans clinical trial management and compliance at institutions such as UT Southwestern Medical Center and Mary Crowley Cancer Research Centers. Yulia holds a Bachelor of Science in Biology from Maryville University of Saint Louis and a Bachelor's degree in Social and Political Sciences from the National University of Uzbekistan.