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_Master of Science, Regulatory Affairs & Services_                                                                                                                                                                   
**Relevant courses**: 510(K) and PMA’s, IVDR and advanced IVDR, International regulatory affairs – EU, Canada, Japan, China, Brazil and Mexico, Legal basis of medical device product regulation, Life cycle of the clinical product, medical device quality, and regulatory fundamentals, Regulatory Affairs Compliance.

St. Cloud State University

Regulatory Affairs/Quality Assurance Intern with 1-year hands-on experience and 2 years masters degree in medical devices. Expertise in global regulatory affairs (US FDA, EU MDR, Health Canada, China, Japan), approval processes, device design, Compliant investigations, and CAPA implementation. Skilled in quality assurance, ensuring product quality and compliance. Goal-oriented, thorough, and enthusiastic contributor to Regulatory and Quality environments.

Maneesha Korrapati

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