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Job Details

Telecommuting Regulatory Affairs Consultant

Location
Baltimore, MD

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A research organization is filling a position for a Telecommuting Regulatory Affairs Consultant.nCore Responsibilities Include: Updating Regulatory Strategy based on FDA feedback and product developments Compiling data and writing FDA package for 510(k) submission Interfacing with FDA during NHP and clinical studies, submission process and FDA auditsnApplicants must meet the following qualifications: Must have at least 5 years of Regulatory Affairs experience Experience working with BARDA 510 (k) FDA submission experience Radiation biodosimetry, RT-PCR diagnostic experience Must be a team player, and be able to work collaboratively with Sponsor and CRO

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