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