Job Summary

A biotechnology company is seeking a Telecommute Regulatory Affairs Consultant.

Candidates will be responsible for the following:

• Interfacing with FDA during NHP and clinical studies
• Compiling data and write FDA package for 510(k) submission
• Updating Regulatory Strategy based on FDA feedback and product developments

Position Requirements Include:

• Travel Type Regional
• Experience working with BARDA is required
• Must have at least 5 years of Regulatory Affairs experience
• 510 (k) FDA submission experience is required
• Radiation biodosimetry, RT-PCR diagnostic experience
• Radiation biodosimetry, RT-PCR diagnostic experience