Our Team
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Kunal Jariwala
Medical Devices Senior Consultant
Mr. Jariwala joined Biologics Consulting in December 2025 as a Senior Consultant specializing in Digital Health. He brings over a decade of experience in regulatory strategy, software quality, and compliance for Software as a Medical Device (SaMD) and AI/ML-enabled healthcare solutions. At Biologics Consulting, he guides clients in developing and executing regulatory strategies to secure product approvals, advises on robust design controls, and supports FDA interactions, including Q-Sub meetings and audit responses. Prior to joining Biologics Consulting, Mr. Jariwala served as Senior Consultant at Devote Consulting Inc., where he architected a SaMD Robustness Framework and modernized Quality Management Systems to integrate Secure Product Development Framework principles.
His earlier roles include Lead Software Quality Engineer at Verily Life Sciences (Google Health), where he directed compliance for AI-enabled platforms, and Senior SaMD QA/RA Engineer at Abiomed (Johnson & Johnson MedTech), where he successfully authored and managed Pre-Sub and De Novo submission for a novel machine learning-based predictive indicator. He began his career in regulatory and quality systems at Delsys Inc., later advancing to senior engineering role at Dräger, where he led compliance initiatives for IEC 62304 and cybersecurity standards to ensure product safety and regulatory alignment.
Mr. Jariwala earned his MBA from Boston University’s Questrom School of Business in 2023, an M.S. from the University of Illinois-Chicago in 2012, and a B.Eng. from the University of Mumbai in 2010. He is a certified Lead Auditor for ISO 13485:2016 and holds an AI in Healthcare Specialization from Stanford University.