Soma Khanra, MSRA

Regulatory Affairs professional with experience supporting FDA 510(k), EU MDR Technical Documentation, and global compliance activities for medical devices and combination products. I’ve worked across design control, risk management (ISO 14971), labeling, and post-market activities, collaborating with cross-functional teams to bring products from development to regulatory readiness. I’m particularly interested in early-stage and growing companies navigating regulatory pathways, where documentation, testing, and strategy alignment are critical. Currently, I also collaborate with teams to support regulatory readiness and testing needs for medical devices and drug-device combination products aligned with FDA, EU MDR, and ISO standards. Always open to connecting with professionals in MedTech, biotech, and regulatory space.