Job Summary

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

Core Responsibilities of this position include:

• Coordinating, compiling, and submitting U.S. and EU regulatory filings for new and modified products
• Preparing regulatory assessments

Skills and Requirements Include:

• Experience in interacting with FDA staff notified bodies
• Have at least 7 years regulatory experience
• Ability to develop domestic and international strategies for regulatory approval of Class II and III medical devices