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Natalie Batty, MPH, CCRA

Sr. Regulatory Affairs Specialist
Aignostics

Natalie Batty, MPH, CCRA has over 7 years of regulatory and clinical affairs experience working with in vitro diagnostics. She has completed multiple FDA submissions (de novos, 510ks, and Emergency Use Authorizations) and has prepared IVD documentation for Canadian and European regulatory agencies.
Natalie started her career in Research and Development working with PCR-based in vitro diagnostic devices for infectious disease testing. She transitioned into the regulatory affairs realm, eventually serving as a regulatory affairs manager for a medical device manufacturing company. In this role, she was responsible for the preparation and management of US regulatory submissions, labeling, and post market surveillance and vigilance. Natalie also has experience with managing IVD clinical studies, and is well-versed in ICH-GCP (Good Clinical Practice) and IVD clinical trial set-up and monitoring activities.
Natalie has a strong technical scientific background with a Bachelor’s degree in biology and chemistry, and a Master’s degree in Public Health from Westminster College in Salt Lake City, Utah.

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