Saahil Sheth
About Saahil Sheth
Saahil Sheth is a Senior Clinical Evaluations Specialist at AtriCure, Inc., where he focuses on preparing safety and performance summaries for Class III medical devices. He has a strong background in biomedical engineering, with previous roles at RQM+ and the National Institutes of Health.
Current Role at AtriCure
Saahil Sheth serves as a Senior Clinical Evaluations Specialist at AtriCure, Inc. since 2023. In this role, he is responsible for preparing and writing Summaries of Safety and Performance for Class III medical devices, ensuring compliance with the European Union Medical Device Regulation (EU MDR). His work involves collaboration with cross-functional departments to develop post-market clinical follow-up plans and reports, as well as annual periodic safety update reports.
Previous Experience at RQM+
Saahil Sheth held multiple positions at RQM+ from 2021 to 2023. He started as a Regulatory Scientist for 11 months in Durham, North Carolina, where he focused on regulatory compliance. He then worked as a Medical Writer for 4 months, followed by a role as a Senior Consultant for 8 months in the Raleigh-Durham-Chapel Hill Area. His experience at RQM+ contributed to his expertise in regulatory submissions and medical writing.
Research Background at National Institutes of Health
In 2018, Saahil Sheth completed a Summer Research Internship at the National Institutes of Health in Bethesda, Maryland. This internship lasted for 3 months and provided him with valuable experience in a research environment, contributing to his overall expertise in biomedical engineering and regulatory affairs.
Education and Academic Achievements
Saahil Sheth earned a Bachelor of Science (B.S.) in Biomedical/Medical Engineering from Saint Louis University, completing his degree in 2015. He continued his studies at the same institution, obtaining a Doctor of Philosophy (Ph.D.) in Biomedical/Medical Engineering in 2019. During his academic career, he also served as a Graduate Research Assistant for 5 years and as an Undergraduate Research Assistant for 2 years, gaining extensive research experience.
Literature Review and Regulatory Submissions Expertise
Saahil Sheth engages in systematic literature search reviews to support regulatory submissions and scientific publications. His role involves ensuring that clinical evaluations are based on comprehensive and up-to-date scientific evidence, which is crucial for compliance with regulatory standards in the medical device industry.