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DIRECTOR, DIGITAL HEALTH REGULATORY AFFAIRS

Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...

CompanyMcra
AddressWest Virginia, United States
CategoryInformation Technology
Job typeFull-Time
Date Posted 24 hours ago See detail

Director, Digital Health Regulatory Affairs New

Mcra

West Virginia, United States

Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...

Clinical Research Associate (CRA)

Mcra

Remote

$75,000 - $100,000 a year

Ensure that monitoring activities (remote and on-site) are completed in accordance with company/client SOPs and Clinical Monitoring Plan. Conduct on-site and remote study monitoring and site management. Assist project manager with...

In-House CRA

Mcra

Remote

$70,000 - $90,000 a year

Review and approve research and study regulatory documents required for the implementation, monitoring, and evaluation of clinical trials. Review clinical protocols to ensure collection of data needed for regulatory submissions Co...

Clinical Trial Associate (CTA)

Mcra

Washington, DC

Support clinical project team by updating and maintaining clinical systems that track site compliance and performance within project timelines. Maintain Trial Master File (TMF) for multiple studies, including supporting periodic r...