Kathleen Aras

Kathleen Aras has extensive experience in regulatory affairs and quality assurance in the medical device industry. Kathleen started their career at MERCK RESEARCH LABORATORIES, where they led process discovery, development, optimization, and scale-up of catalytic processes and fermentations. Kathleen then moved on to PrognostiX, Inc., where they established necessary equipment and processes for product development and validation. At PROGNOSTIX, INC, they also established cGMP-compliant facilities. Kathleen later joined SDG, INC as a Director, overseeing all aspects of product development, manufacturing, and distribution. Kathleen Aras then worked at Cleveland HeartLab, Inc. as the Director of Regulatory Affairs, leading the company through successful FDA inspections. Most recently, they served as the Assistant Vice President of Regulatory Affairs & Quality Assurance at Quality Electrodynamics (QED), developing and executing global regulatory strategies and overseeing product registrations and quality assurance systems.

Kathleen Aras completed a Bachelor of Science degree in Chemical Engineering from Ohio University from 1994 to 1998. Later, from 1998 to 2000, they pursued a Master of Science degree in Chemical Engineering from Vanderbilt University. Both degrees were obtained in the field of Chemical Engineering.