Remote Principal Regulatory Specialist

Job ID: Available for Members

Location: Nationwide

Compensation: Salary

Posted: Thursday, February 22, 2018

Job Category: Healthcare

Telecommute Level: 100% Telecommute

Travel Requirements: No Travel

Employment Status: Permanent

Employer Type: Staffing Agency

Career Level: Experienced

Additional Information: Benefits Available

Job Summary

A staffing agency is searching for a person to fill their position for a Remote Principal Regulatory Specialist.

Core Responsibilities of this position include:

  • Manage some of the largest submissions in the company
  • Clearly communicate critical data to FDA
  • Lead the effort in the preparation of high-priority regulatory submissions in new therapeutic areas

Must meet the following requirements for consideration:

  • Must have taken a new PMA from start to finish
  • Experience with regulatory submissions
  • Experience with pre and post-approval studies
  • Experience with FDA and EU-MDR approvals
  • Experience with regulatory strategy
  • Experience with IDEs