Dan Modi
Compliance Consultant - Quality System & Regulatory Standards @KARL STORZ North America
Irvine, CA, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Jan 2015 — Present
Compliance Consultant - Quality System & Regulatory Standards @KARL STORZ North America
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Santa Barbara, CA, US
EDUCATION
1982 — 1985
M.S University of Baroda, India
B.S - Electronics Engineering, Major: Intrumentation
1997 — 2000
Pepperdine Graziadio Business School
MBA
2001 — 2003
UC Irvine
Certificate, Medical Product Development
SKILLS
Iec 60601 Series Electro-Medical StandardsRegulatory RequirementsBiotechnologyResearch and Development (R&D)21 Cfr 820Biomedical EngineeringMedical Device Design Control21 Cfr Part 11Regulatory AffairsRegulationsVerification and Validation (V&V)Iso 13485Iec 60601Design ControlProduct DevelopmentTrainingTestingMedical DevicesCapaR&D21 CfrValidationU.s. Food and Drug Administration (Fda)SopChange ControlGmpFdaCross-Functional Team LeadershipRegulatory SubmissionsQuality SystemV&V
ABOUT DAN MODI
Design Quality & Regulatory Professional.
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