Telecommute Regulatory Affairs Manager

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Thu, Oct 11, 2018

Job Category: Healthcare

Telecommute Level: Occasionally

Travel Requirements: Field Travel Required, Some Travel

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A contract research organization has a current position open for a Telecommute Regulatory Affairs Manager.

Core Responsibilities Include:

  • Preparing, submitting, and managing regulatory clearance applications required for product market approvals
  • Preparing and submitting USFDA Regulatory submissions
  • Submitting and managing domestic product listings

Must meet the following requirements for consideration:

  • Travel nationwide
  • 7-10 years of experience in regulatory and/or quality assurance in a IVD medical device development and manufacturing environment
  • Expertise and understanding of Class III IVD product entry into the US market
  • Specific experience with US submissions for Medical Device and IVD products.
  • Skilled at interfacing with the FDA/CDER/OIR
  • Prior project management experience