Job Summary

A staffing agency has a current position open for a Remote EU Region Principal Regulatory Affairs Specialist in Los Angeles.

Core Responsibilities of this position include:

• Working with RAS, engineers, and technical experts to resolve potential regulatory issues
• Obtaining approval to ensure the continued regulatory compliance of existing products
• Reviewing remediated documentation and pulling together EU MDR submissions

Applicants must meet the following qualifications:

• Bachelor's degree
• 5+ years of regulatory experience in the medical device, biotech, or pharmaceutical industry
• Experience in regulatory submissions, Investigational Device Exemption
• Experience in EU technical files for Class IIa/IIb
• Experience in design dossiers for Class III, PMA supplements, drug or biologics submissions