Telecommute Regulatory Affairs Consultant

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Posted: Friday, April 06, 2018

Job Category: Business Operations

Telecommute Level: Occasionally

Travel Requirements: Field Travel Required, Some Travel

Weekly Hours: Part Time

Employer Type: Employer

Career Level: Experienced

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