Parthiv Shah, Ms (Ee)
About Parthiv Shah, Ms (Ee)
Parthiv Shah is a Senior Regulatory Affairs Specialist at Vital Images, Inc., where he has worked since 2011. He holds two Master's degrees, one in Electrical and Electronics Engineering from San Jose State University and another in Regulatory Affairs Services from St. Cloud State University.
Current Position at Vital Images, Inc.
Parthiv Shah serves as a Senior Regulatory Affairs Specialist at Vital Images, Inc., a role he has held since 2011. With over 13 years of experience in the Greater Minneapolis-St. Paul Area, he is responsible for ensuring compliance with regulatory requirements for medical devices. His work involves managing submissions and communications with regulatory bodies, contributing to the company's adherence to industry standards.
Education and Expertise in Regulatory Affairs
Parthiv Shah holds two Master's degrees. He studied Electrical and Electronics Engineering at San Jose State University from 2007 to 2009. He then pursued a Master's degree in Regulatory Affairs Services at St. Cloud State University, completing his studies from 2010 to 2015. His educational background equips him with the technical knowledge and regulatory expertise necessary for his current role.
Regulatory Submissions and Compliance
In his role, Parthiv Shah has managed and submitted ten 510(k) notifications to the FDA, demonstrating his proficiency in regulatory submissions. He has also authored regulatory plans that outline pathways for new products and product changes, ensuring comprehensive regulatory assessments are conducted. His experience includes submitting five Medical Device Reports (MDRs) as part of his regulatory responsibilities.
Recall Management and Reporting
Parthiv Shah has successfully managed and initiated five recalls, closing two of them. His responsibilities included drafting recall letters and notifying the necessary regulatory bodies. Additionally, he provides monthly status reports to regulatory agencies, ensuring that all required communications are maintained and compliance is upheld.