Duration
- 2 years +
Job Description
Our pharmaceutical client needs a strong GCP QA Consultant with a strong background in Medical Device. GCP and Device experience are a must as they do not have in-house medical device experience. Ideally, this person will need to train the team on Medical Device regulations. They have a department of 14 professionals who have little to no experience regarding Medical Device in QA GCP and this person will need to spend time training these individuals and get them up and running on the device side of things. The device being worked on is an implantable but they also have an inhaler product. The client needs someone who knows the regulations of what is allowed. The client is currently in phase 3 but would like the consultant to have knowledge in phase 1-4 in trials for clinical devices. They will need to manage the landscape for the different phases from 1-4. Must have strong risk background and a thorough understanding of U.S. regulations for day to day clinical trials.
Skills
- GCP, QA, Medical Device, Training in Medical Devices
Education
- B.S. in scientific field preferred.
Remote: GCP QA Medical Device SME (235010)
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