Alexia Haralambous, is Vice President of Regulatory Affairs at AlvaMed. Alexia has over a decade of experience spanning the FDA, MedTech industry, and consulting, including serving as a former FDA reviewer. She has supported diverse technologies across therapeutic areas including cardiovascular, neurology, respiratory, women’s health, urology, interventional radiology, ophthalmology, gastroenterology, oncology, and orthopedics. She spent the first part of her career focused on spine and orthopedic devices and now specializes in practical, efficient regulatory strategies and submissions that help companies bring innovative technologies to market, with particular expertise in digital health, SaMD and AI/ML-enabled devices, wearables, and enabling technologies. Alexia works extensively with early‑stage and venture‑backed startups and also brings experience from working within a large Fortune 500 MedTech company.

Contact Alexia Haralambous directly to talk about your project.