Sowmya Senthil
Chief Regulatory Officer @Qualentra Global Private Limited
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WORK HISTORY
Chief Regulatory Officer @Qualentra Global Private Limited
Leads complex regulatory strategies and submissions for diverse device portfolios—ranging from electromechanical systems to SaMD/SiMD—covering key regulations and agencies including:US FDA – 510(k), QSR, Labeling, Establishment RegistrationEU MDR – GSPR, Technical Documentation, NB InteractionsCDSCO (India) – MD-12/MD-26, Import & Manufacturing LicensesOther global markets – MENA, LATAM, SEA, ANVISA, TGA
EDUCATION
Sri Sivasubramaniya Nadar College Of Engineering
Bachelor of Engineering - BE, Biomedical/Medical Engineering
ABOUT SOWMYA SENTHIL
Global Regulatory Affairs Leader with a decade of cross-market experience. A…
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