100% ONSITE BURLINGTON MA
PAY: $30-$40/hr
REQUIRED:
BS in Biomedical Engineering/Bioengineering
Academic or internship experience with FDA regulations
MS Excel (pivot tables)
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.
