Alexia Haralambous, MS, RAC

Hi, I’m Alexia. I help MedTech teams - from scrappy startups to Fortune 500 companies - figure out what needs to get done to reach the market and roll up my sleeves to make it happen.

I’ve spent 12 years across the regulatory world: reviewing submissions at the FDA, leading teams at Stryker, and consulting at RQM+. That perspective helps me turn complex challenges into clear, practical steps. Strategy matters, but I’m equally hands-on. I write and lead FDA and global submissions while partnering with product, clinical, engineering, and executive teams to shape claims, testing, and FDA interactions from concept to approval.

I’ve supported a wide range of products - software, AI/ML tools, wearables, robotics, and consumer health tech, to name a few - and worked across diverse therapeutic areas including cardiovascular, neurology, respiratory, women’s health, urology, interventional radiology, ophthalmology, gastroenterology, oncology, and orthopedics. My approach is precise, practical, and future-focused, cutting through the noise to focus on what matters most for your product and your timeline.

Startups and early-stage teams hold a special place in my heart. I get the pressure to move fast, stay lean, and make regulatory choices that actually support fundraising and product development rather than slow it down.

I hold a BS and MS in Biomedical Engineering from Johns Hopkins University and am RAC-certified. At the end of the day, my goal is simple: to be a regulatory partner you can trust to get safe, meaningful technologies to patients efficiently and confidently.

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