Recent Graduate Biomedical​/Bioengineer; FDA project exp

Academic or internship experience with FDA regulations

Must have organizational skills.

Will be working with a complex product which is a heart pump in managing the day-to-day events and qualitative data related to product and patient information coming in from the field

Must have excellent communication, organizational, attention to detail, and time management skills; will be using MS office suite with basic Excel working knowledge

A person that has juggled a job and school or a sport and school is a good candidate

Job Description:

This is not a hands on position or R&D. This will be on the Regulatory Affairs/Quality side of things. Working with post market surveillance of explanted, failed, returned medical devices. Updating databases and writing reports for the FDA. Writing/generating the applicable reports, updating the databases.