Raju K Mishra

Quality & Regulatory Leader | RAPS Member | Medical Device SaMD and AI Expert | ISO 13485 | FDA 21 CFR | EU MDR | Risk Management | Regulatory Affairs Specialist | Global Regulatory expert

Role
Regulatory Affairs Specialist at Tata Elxsi
Location
Pune District, MH, IN
LinkedIn followers
500 followers

About Raju K Mishra

Driving Regulatory Excellence in Medical Devices, SaMD, & AI With 9+ years of…

Experience

  1. Regulatory Affairs Specialist

    Tata Elxsi

    Jan 2024 — Present · Pune, IN

    QMS integration program planning, gap analysis, Remediation and QA Support, EU AI Act Gap assesment.501k support, Global regulatory submission support, EUMDR, 21CFR 820, SaMD

Education

  • APJ Abdul Kalam Technological University

    B. Tech, Mechanical Engineering

    2012 — 2016

  • Indian Biomedical Skill Consortium (IBSC)

    Certificate in Biomedical Quality Assurance, Medical device

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Raju K Mishra — Regulatory Affairs Specialist at Tata Elxsi in Pune District, MH, IN | Unifers