Our pharmaceutical client needs a strong GCP QA Consultant. GCP and Device experience a must as they do not have in-house medical device experience. Device is an implantable but they also have an inhaler product. Client needs someone who knows the regulations of what is allowed. Going to first in human trials hopefully through to phase 3. What are rules and regulations for phase 1-4 in trials for clinical devices. Manage the landscape for the different phases from 1-4. They are in site activation mode. Need to be able to lean on them for trials requirements for medical devices. Must have strong risk. Trials are global. A nice plus would be for EU standards. Must have U.S. regulations for day to day clinical trials.
GCP, QA, Medical Device
B.S. in scientific field preferred. GCP experience most important.
Remote: GCP QA Medical Device SME (233242)