Telecommute Medical Device Regulatory Affairs Manager

Job ID: Available for Members

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Mon, Dec 09, 2019

This job expires in 25 days

Job Category: Healthcare

Telecommute Level: 100% Telecommute

Travel Requirements: No Travel

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Manager

Education Level: Bachelors

Job Summary

A medical contract research organization is searching for a person to fill their position for a Telecommute Medical Device Regulatory Affairs Manager.

Candidates will be responsible for the following:

  • Submit and manage domestic product listings
  • Prepare, submit, and manage regulatory clearance applications
  • Participate as subject matter expert in internal and external quality system

Must meet the following requirements for consideration:

  • Specific experience with US submissions
  • BA/BS degree is required
  • 7-10 years of experience in regulatory and/or quality assurance
  • Skilled at interfacing with the FDA/CDER/OIR