REGULATORY AFFAIRS SPECIALIST
Joined: November 11, 2025
Since joining Innolitics in November 2025, I have managed 13+ regulatory engagements across 510(k), De Novo, Breakthrough Device Designation, and Pre-Sub pathways, submitting 2 510(k)s and 5 Pre-Subs in 2026. Before joining Innolitics, I ran quality and regulatory for a neuromonitoring SaMD company, where I built an eQMS compliant with 21 CFR 820, ISO 13485, and IEC 62304, authored 35+ technical documents to support a class II SaMD regulatory submission, and led ISO 14971 risk management activities. I hold BS and MS degrees in Biomedical Engineering from Drexel University. Outside work, I play basketball and squash, and hunt down the best happy hour spots in any city I visit.
I am a quality, regulatory, and project management consultant with experience in various medical device industries, such as neuromonitoring, ophthalmology, laparoscopy, and orthopedics. I graduated from Drexel University with my Bachelor’s and Master’s degrees in Biomedical Engineering with focuses in Neuroengineering and Biomechanics. I am interested in all things medical device, and looking forward to work on a variety of projects in the SaMD space.
Outside of work, I am a baseball and basketball aficionado. You can always find me playing basketball, squash, racquetball, or any other sport whenever the gym is open. On rainy days, I enjoy nothing more than playing sudoku and building Legos. I am a huge foodie, and I love exploring the best restaurants & happy hours that cities have to offer!
Basketball, baking, academic tutoring, video games, legos, random SWE side projects