Ameera Roubi

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.