Remote Regulatory Affairs Manager

Job Summary

A medical contract research organization is seeking a Remote Regulatory Affairs Manager.

Core Responsibilities Include:

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

Required Skills:

• 7-10 years of experience in regulatory and/or quality assurance
• BA/BS degree
• 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