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Chitra Nadig

Sr Director Quality, Regulatory and Compliance @Kandu

Oak Park, CA, US
EMAILS
[email protected]
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jan 2026 — Present

Sr Director Quality, Regulatory and Compliance @Kandu

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Van Nuys, CA, US

EDUCATION

2002 — 2004

University of Southern California

MS, Biomedical Engineering

SKILLS

System TestingTestingIso 13485Quality AssuranceSoftware Quality AssuranceFdaQuality SystemDesign ControlIso 1497121 Cfr Part 11Medical DevicesR&DV&VLabviewValidation21 CfrCorrective and Preventive Action (Capa)U.s. Food and Drug Administration (Fda)Cross-Functional Team LeadershipFailure Mode and Effects Analysis (Fmea)Biomedical Engineering

ABOUT CHITRA NADIG

Accomplished Quality and Regulatory Affairs leader with over 20+ years of experience in the medical device, digital health, and combination product industries. Proven expertise in building and scaling quality systems compliant with GMP, ISO 13485, 21 CFR 820, and IEC 62304. Skilled in driving design controls, risk management, and regulatory strategies across hardware, software, and integrated systems. Experienced in leading cross-functional teams across R&D, manufacturing, cybersecurity, and regulatory functions to ensure compliance and support business growth. Strong track record of supporting successful regulatory submissions, global certifications, inspection readiness, and QMS optimization. Known for fostering high-performing teams and instilling a culture of quality, accountability, and continuous improvement.

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