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. Over the course of her career, Alexia has:
Regulatory Affairs
- Worked with companies ranging from early-stage startups to large multinational organizations to define regulatory pathways and execute successful FDA submissions.
- Led and authored a wide range of submissions including Pre-Submissions, 510(k)s, De Novos, PMAs, and IDEs, guiding products from early concept through commercialization.
- Served as a primary liaison with FDA, leveraging prior agency experience to support clear communication, address regulatory challenges, and facilitate efficient review processes.
- Brought deep experience across digital health technologies, including software, AI/ML, wearables, and connected devices, aligning innovative products with regulatory expectations.
- Supported both new product development programs and postmarket/sustaining regulatory activities, ensuring compliance and continuity across the product lifecycle.
- Directed global regulatory strategy, supporting submissions and market access across the US, EU, UK, Canada, Australia, Japan, China, and other major markets.
- Supported regulatory due diligence and integration efforts for mergers and acquisitions, providing strategic insight to inform business decisions.
Quality & Clinical Strategy
- Advised clients on building and maintaining compliant, right-sized quality systems aligned with ISO 13485 and FDA requirements.
- Provided guidance on risk management, design controls, and product development strategies to support successful regulatory outcomes.
- Supported clinical and regulatory planning to align development programs with approval and commercialization goals.
FDA Experience
- Served as a lead reviewer within FDA’s Center for Devices and Radiological Health (CDRH), evaluating a range of medical device submissions including 510(k)s, PMAs, IDEs, and Pre-Submissions.
- Provided detailed feedback to industry on device safety and effectiveness, including clinical, nonclinical, and engineering considerations.
- Collaborated with cross-functional FDA teams to support regulatory decision-making and development of review recommendations.
- Contributed to FDA guidance development and supported scientific research efforts related to device evaluation.
Alexia holds a BS and MS in Biomedical Engineering from Johns Hopkins University and is Regulatory Affairs Certified (RAC).
