Nainesh Sureja
About Nainesh Sureja
Nainesh Sureja is the Director of Regulatory Affairs at Boston Scientific, with extensive experience in regulatory roles at various medical technology companies.
Director of Regulatory Affairs at Boston Scientific
Nainesh Sureja currently holds the position of Director of Regulatory Affairs at Boston Scientific. He started in this role in 2021. In this capacity, he oversees the regulatory strategies and compliance measures to ensure product approvals and adherence to industry standards.
Previous Experience at FARAPULSE, Inc.
Before joining Boston Scientific, Nainesh Sureja worked as the Director of Regulatory Affairs at FARAPULSE, Inc. from 2020 to 2021. During his 10-month tenure, he was responsible for the regulatory approval processes and maintaining compliance with medical device regulations.
Regulatory Affairs at Profusa
Nainesh Sureja served as the Director of Regulatory Affairs at Profusa from 2018 to 2020 in the San Francisco Bay Area. He managed regulatory submissions and led efforts to secure approvals for new medical technologies.
Roles at Medtronic
Nainesh Sureja has a significant history with Medtronic, having worked in various capacities from 2009 to 2018. He started as an Associate Regulatory Affairs Specialist and eventually became a Regulatory Affairs Manager. His roles at Medtronic included positions such as Sr. RAS, Principal Regulatory Affairs Specialist, and Regulatory Affairs Manager. Each role involved increasing responsibilities in managing regulatory processes and compliance.
Education and Expertise
Nainesh Sureja has a strong educational background in Biomedical Engineering. He earned a Master's degree from the University of Southern California between 2007 and 2008. He also holds a Bachelor of Engineering degree from the University of Mumbai, completed from 2003 to 2007. Additionally, he participated in the RAPS Executive Development Program at Northwestern University - Kellogg School of Management in 2016.