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Chitra Nadig

Director of Quality and Regulatory
KeborMed

Chitra Nadig, MS, CMQ/OE, Certified Medical Device Auditor
Director of Quality and Regulatory, KeborMed

Chitra Nadig is the Director of Quality and Regulatory at KeborMed, bringing over 20 years of experience in the medical device, digital health, and combination product industries. With a strong foundation in biomedical engineering and certifications including CMQ/OE, Medical Device Auditor, and Green Belt, Chitra has led quality and regulatory functions across startups and global corporations alike.

She has played a pivotal role in building ISO 13485 and 21 CFR 820-compliant quality systems from the ground up and has deep expertise in software quality, SaMD, cybersecurity, and FDA regulatory submissions. Chitra has successfully led cross-functional teams through audits, 510(k) submissions, and the development of Master Files for cloud-based operating platforms.

Prior to her current role, Chitra held leadership positions at Amgen and Medtronic Diabetes, where she drove enterprise-level quality improvements, remediation programs, and risk management strategies aligned with ISO 14971 and evolving global regulations.

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