Telecommute Regulatory Affairs Consultant

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Posted: Monday, March 12, 2018

This job expires in 19 days

Job Category: Business Operations

Telecommute Level: Occasionally

Travel Requirements: Field Travel Required, Some Travel

Employer Type: Employer

Career Level: Experienced

Weekly Hours: Part Time

Job Details

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