Subhadra Elango
Manager, Regulatory Affairs @Balt Usa
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WORK HISTORY
Manager, Regulatory Affairs @Balt Usa
EDUCATION
UC San Diego
Bachelor's Degree, Bioengineering, Bioinformatics
The Johns Hopkins University
Master of Science - MS, Regulatory Sciences
ABOUT SUBHADRA ELANGO
A seasoned regulatory professional specializing in the medical device industry. Possesses a strong foundation in regulatory affairs, quality management, compliance, and clinical research. With expertise in FDA submissions (510(k), PMA, IDE), EU MDR (Class Ila, IIb, and Health Canada (Class II, IV). Has a proven track record of harmonizing business, marketing, regulatory, and compliance strategies to achieve effective cross-franchise tactical implementation. As an accomplished manager and consultant, led high-performing teams, providing successful mentorship and training, while also fostering consensus building.
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