Remote Regulatory Affairs Manager in Norfolk

Job ID: Available for Members

Location: Virginia

Compensation: To Be Discussed

Staff Reviewed: Mon, Feb 11, 2019

This job expires in 20 days

Job Category: Healthcare, Project Management

Telecommute Level: Majority

Travel Requirements: Possible Travel

Weekly Hours: Full Time

Employment Status: Permanent

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A medical contract research organization is in need of a Remote Regulatory Affairs Manager in Norfolk.

Core Responsibilities Include:

  • Preparing, submitting, and managing regulatory clearance applications
  • Submitting and managing domestic product listings
  • Leading and completing labeling reviews

Required Skills:

  • 7-10 years of experience in regulatory and/or quality assurance
  • BA/BS degree is required
  • Expertise and understanding of Class III IVD product entry
  • Specific experience with US submissions for Medical Device and IVD products
  • Skilled at interfacing with the FDA/CDER/OIR
  • Prior project management experience