Sofia Espada Email & Phone Number

Indianapolis, In, Us

Indianapolis, Indiana, United States

Bloomington, Indiana, United States

-Assess complaints of interventional radiology devices based on FDA 21 CFR guidelines, device risk analysis, and past reporting practices-Prepare Medical Device Reports (MDR) for the FDA and EU Medical Device Vigilance Reports to satisfy submission deadlines set by regulatory agencies-Collaborate with Quality Engineering and other Cook entities to ensure timely notification of additional information to the FDA and European competent authorities -Communicate with regulatory bodies about adverse events and product malfunctions of medical devices-Responsible for tracking of late initial reports and ensuring action items are completed to prevent it from recurring-Represented the Regulatory Reporting team in the Ethics and Compliance Risk Mitigation Pilot Project in which compliance risks within the subsystem, along with several other departments within Cook, were preliminarily identified

-Experiments involving Steinernema nematodes as a model system for studying parasite virulence and within host interactions-Designed and optimized species specific primers for qPCR with the purpose of identifying and quantifying four nematode species -Analyzed results of qPCR graphically using statistical computing via R programming-Effectively trained new undergraduate members on lab techniques: DNA isolation/extraction, PCR, gel electrophoresis, and qPCR.

Indianapolis, Indiana Area

-Learned mammalian cell culture techniques: actively participated in the experimental design and selection of reporter cell lines intended for biotherapeutic research targeting autoimmune diseases- Contributed to the development and optimization of protocols for automating large panel Taqman qPCR experiments using 384-well and 96-well Nimbus robot platforms