Joseph Ortiz

I supported U.S. regulatory planning at MetaSano for an AI-powered Stage 3 chronic kidney disease self-management platform.

I contributed to a draft FDA Q-Submission, proposed Indications for Use, algorithm performance evaluation plans, and clinical validation requirements. I also assessed potential 510(k) pathway considerations, future adaptive AI changes, subgroup performance, documentation, and post-market needs.

As a Clinical Sales Specialist at Consignmed, I provide intraoperative technical support, device preparation, troubleshooting, and clinician training across hospital accounts. I work directly with surgeons, nurses, operating room personnel, and purchasing stakeholders to promote safe and effective device use.

I'm building on my MS in Regulatory Affairs with a biopharmaceutical concentration and a foundation in biology and medical education. My work combines FDA pathways, GxP, quality documentation, labeling, regulatory submissions, and practical medical-device experience.