Dharamveer Gajaria
About Dharamveer Gajaria
Dharamveer Gajaria is a Regulatory Manager at Silk Road Medical, Inc. in the San Francisco Bay Area with extensive experience in regulatory affairs and biomedical engineering.
Title
Dharamveer Gajaria is currently serving as a Regulatory Manager at Silk Road Medical, Inc. in the San Francisco Bay Area.
Professional Experience at Silk Road Medical, Inc.
Dharamveer Gajaria is currently employed at Silk Road Medical, Inc. in the capacity of Regulatory Manager. His role involves providing direction to cross-functional teams in planning and executing product development activities, ensuring compliance with regulatory standards and protocols.
Previous Roles at Intersect ENT, Inc. and Medtronic
In 2019, Dharamveer Gajaria held the position of Principal Regulatory Affairs Specialist at Intersect ENT, Inc. in Menlo Park, California for four months. Prior to that, he had multiple roles at Medtronic, including Principal Regulatory Affairs Specialist and Regulatory Affairs Program Manager for four months in 2019, Senior Regulatory Affairs Specialist from 2017 to 2018, and Regulatory Affairs Specialist from 2015 to 2017.
Experience at Optiscan Biomedical
From 2019 to 2020, Dharamveer Gajaria served as Director of Regulatory Affairs at Optiscan Biomedical in Hayward, California. Here, he was responsible for leading regulatory submissions and interactions with regulatory agencies for products, including medical devices and combination products.
Early Career at HOSMAC India Pvt. Ltd.
In the earlier stage of his career, Dharamveer Gajaria worked as a Biomedical Engineer at HOSMAC India Pvt. Ltd. in Mumbai, India from 2012 to 2013. In this role, he contributed to various biomedical projects and provided technical support for product development.
Education and Expertise
Dharamveer Gajaria holds a Master of Science (M.S.) in Regulatory Science from the University of Southern California. He also earned a Bachelor of Engineering (B.E.) in Biomedical Engineering from the University of Mumbai. His education has equipped him with extensive expertise in regulatory strategies for medical devices, combination products, drugs, and biologics.
Regulatory Submissions and Management Representative Activities
Dharamveer Gajaria has significant experience in leading interactions with regulatory agencies for various regulatory submissions, including Investigational Device Exemption (IDE) and Premarket Approval (PMA). He also conducts Management Representative activities per ISO 13485 standards and provides direction to cross-functional teams during design control activities.