Anushree Srivastava joins us a Clinical Evaluation Scientist – Contract. Anushree has Bachelor of Engineering from the University of Mumbai and a Master’s in Biomedical Engineering from Stony Brook University, New York. She is also a BSI-certified Internal Auditor for ISO 13485:2016 and has worked on Design History File (DHF) development and remediation projects.
She began her career as a Staff Research Associate at the Columbia University Medical Center in New York, wherein she worked on the application of focused ultrasound for opening the blood-brain barrier in drug-delivery. She later went on to work with Beckman Coulter India as a Development Scientist, after which she transitioned into medical writing. Most recently, Anushree led the Clinical Affairs vertical in the MedTech QARA department and managing a team of 18+ scientific writers.
Anushree combines a technical understanding of medical devices with her experience in RA, QA and #medicalwriting, to partner with clients globally and provide regulatory solutions tailored to the product’s requirements. She has experience in writing CERs and CEPs for the EU and China regions; and PMS Plans/Reports, PSURs, SSCPs, and scientific literature reviews for EU and US-FDA projects.
Welcome, to the team, Anushree!