Puja Mishra
Regulatory Affairs Executive @Mehra Eyetech Private Limited
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WORK HISTORY
Regulatory Affairs Executive @Mehra Eyetech Private Limited
IN
EDUCATION
Jaypee University of Information Technology
Master of Technology - MTech
Sharda University
Bachelor of Technology
ABOUT PUJA MISHRA
As an accomplished Regulatory Affairs Executive with a robust background in the medical device industry, I excel in navigating intricate regulatory landscapes, ensuring compliance, and achieving successful outcomes. With a proven track record, I specialize in preparing and reviewing diverse regulatory documents, managing government sites like CDSCO, DGFT, and CPCB, conducting internal audits, implementing SOPs, and upholding ISO 13485 standards. My expertise extends to facilitating international agreements, overseeing export operations, and establishing streamlined document management systems. I have extensive experience managing CDSCO applications for medical devices and IVDs, including Import Licenses, Test Licenses, Manufacturing Licenses, and Post-approval submissions. Proficient in CPCB compliances, I handle e-waste regulations comprehensively, from obtaining certificates to fulfilling Extended Producer responsibilities through annual compliances. Committed to continuous learning, I stay abreast of regulatory developments and industry trends to drive compliance and operational excellence.
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