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
Regulatory Affairs Specialist
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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