Nivedha Subramanian Mdr
Regulatory Affairs Associate @SCIEX
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WORK HISTORY
Regulatory Affairs Associate @SCIEX
Concord, ON, CA
EDUCATION
Rajalakshmi Engineering College
Bachelor of Engineering
Northeastern University
Master's degree - MS in Regulatory Affairs
ABOUT NIVEDHA SUBRAMANIAN MDR
I am a biomedical engineer turned regulatory affairs professional with 6+ years of experience in the medical device industry. My expertise encompasses ISO/IEC standards, FDA, Health Canada, and EU regulatory submissions, quality management, change control, post-market surveillance(complaint management, adverse event reporting), regulatory writing, and audits. Trained as Lean Six Sigma Black Belt, I excel in root cause analysis and 8D CAPA processes. My regulatory volunteering includes organizing training programs, study sessions, and contributing to organizations like RAPS, CSA, and SCC.
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