Remote: GCP QA Medical Device SME (233242)

Life Sciences & Technology

Job Description:

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)



About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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