Job Summary

A research organization is filling a position for a Telecommuting Regulatory Affairs Consultant.

Core 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 audits

Applicants 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