ASSOCIATE QUALITY/REGULATORY SPECIALIST
Joined: August 18, 2025
I submitted three 510(k)s in my first year at Innolitics, including Zeto's New Wave EEG system (K260455), which FDA cleared in 30 days with no hold. I have advised on and managed a variety of regulatory engagements, including Breakthrough Device Designation, De Novo, 510(k) submissions, and supported five Pre-Submissions through their FDA meetings. My experience covers a diverse range of medical technologies, including EEG, dental AI, radiology, mental health, surgical guidance, and other AI/ML-enabled software as a medical device. I also serve as project manager, coordinating cross-functional teams, client deliverables, and FDA-facing activities. I hold a BS in Biomedical Engineering from the University of Texas at Austin.
I am a Quality and Regulatory Affairs consultant supporting FDA submissions for AI/ML-based Software as a Medical Device (SaMD). Since joining Innolitics, I've had the opportunity to work across a wide range of device types and regulatory pathways, from 510(k)s and De Novo submissions to Breakthrough Device Designations and Pre-Submissions, spanning radiology, dental AI, mental health, and surgical guidance devices. I graduated from the University of Texas at Austin with a degree in Biomedical Engineering. I'm passionate about helping innovative medical technologies reach the people who need them. When I'm not working, you'll usually find me exploring new coffee shops or spending time with friends and family.
traveling, outdoor activities, trying new foods