Devi Guttapalli

Background

About Devi Guttapalli

Regulatory Affairs Associate, Leadership Program, 01/2023 – Present Regulatory Affairs professional taking part in the Leadership Program to accelerate understanding and experience with regulatory affairs fundamentals and applications. Key Learnings: • Developed a working knowledge of US and Global medical device and pharmaceutical regulations. • Familiar with numerous regulatory document types, including Technical Documentation, 510(k)s, PMAs, and letters to file. • Gained experience with the creation and update of regulatory submissions and documentation. • Familiar with utilization of standards, design controls, new product development, and quality systems requirements. • Experienced and learned from functional areas adjacent to regulatory, including Quality, Packaging, Labeling, and Project Management. • Understanding of the expectations and requirements of Quality Audits and Inspections, both internal and external, in an FDA regulated environment. • Experience and understanding of the creation, implementation, and maintenance of a medical device Quality Management System (QMS).