Prajna U Shetty

Experience

• 

  Innaumation Medical Devices Private Limited

  Jun 2019 - Aug 2019

  Intern

  Medical device startup working on area of voice restoration for throat cancer patients Spearheaded development of solution for mechanically intubated patients to communicate with others. Utilized research findings to conceptualize and develop initial working prototypes.

• 

  Nesa Medtech

  Feb 2020 - May 2023

  Over the course of three rewarding years as a Regulatory Engineer at Nesa Medtech, I actively contributed to the development of regulatory strategy and ensuring compliance for the Indian and US market. I have handled 510K submission for Class B SaMD, FDA pre submission meetings for Class II medical device, Indian regulatory submission for Class C device. Authored V&V reports, design control documents and risk management activities, including design history files, FMEAs, CAPAs, Use Specifications and Use-related risk analyses. Reviewed clinical and technical publications which increased efficiency of research team. Led usability & human factor engineering testing for early product prototypes and final product validation studies.

  • Regulatory Engineer

    Jul 2020 - May 2023

  • Intern

    Feb 2020 - Jun 2020
• 

  Freelance

  Jun 2023 - Aug 2023

  Regulatory Affairs Consultant

  Developed regulatory strategies for Class A, B and C respiratory devices for the Indian market. Handled regulatory submission and provided consultation for ensuring regulatory compliance.

• 

  Georgia Institute of Technology

  Aug 2023 - Dec 2023

  Graduate Teaching Assistant

  Working as a teaching assistant under Dr. Scott Hollister for Regulatory and Quality Issues in Medical Device Development (BMED 4803).Conducting discussion on topics like regulatory issues, design controls and evaluating assignments and quizzes. Assisting students to understand concepts, explaining complex topics and clarifying doubts.

• 

  VentureLab at Georgia Tech

  Sept 2023 - Dec 2023

  Entrepreneurship Assistant

  Working as an entrepreneurship assistant for a project on ECMO non-clotting connectors. Identifying customers and developing value propositions. Connecting with potential customers and conducting discovery interviews to understand their perspective and feedback and report it back to the team.