AlvaMed is pleased to announce that Alexia Haralambous, MS, RAC has joined the firm as Vice President of Regulatory Affairs, where she will lead and continue to expand the company’s regulatory consulting practice.
Alexia brings over a decade of experience across the FDA, MedTech industry, and consulting, including serving as a former FDA reviewer. She has extensive expertise in U.S. and global regulatory strategy and submissions, supporting a broad range of medical technologies across multiple therapeutic areas. She has particular depth in digital health, including software as a medical device (SaMD), AI/ML-enabled technologies, and connected devices, building on an early-career foundation in spine and orthopedic devices.
Throughout her career, Alexia has partnered with organizations ranging from early-stage startups to large multinational companies, guiding products from concept through commercialization. She has led and authored a wide range of regulatory submissions – including Pre-Submissions, 510(k)s, De Novos, PMAs, and IDEs – and has served as a primary liaison with FDA, helping clients navigate complex regulatory pathways with clarity and efficiency.
Her experience within FDA, combined with her hands-on consulting and industry experience, provides valuable insight into agency expectations and review processes, enabling her to develop practical, strategic approaches that support successful outcomes. In addition, Alexia brings experience in quality systems, risk management, and clinical strategy, allowing her to support clients across the full product lifecycle.
Please join us in welcoming Alexia to the AlvaMed team.
Read Alexia’s full bio here.
