Highly motivated and strategic minded regulatory affairs professional with 13 years of experience in medical devices. Having worked on both sides of the aisle as both a regulator with FDA as well as an RA Specialist with leading medical device companies I bring a unique perspective to my field. I have strong project management skills including issue identification and resolution, communication and attention to detail. These skills have been critical in my role as a Lead Reviewer on 50+ premarket submissions while at the Agency, and contributed to successfully leading several submissions (510(k), PMA, and Design Dossier) to approval while in the industry.