Job Summary

A staffing agency is in need of a Remote Medical Device Regulatory Specialist in Minneapolis.

Candidates will be responsible for the following:

• Reviewing and approving documents to meet MDR requirements
• Providing regulatory guidance and support to team including regulatory filing strategies, testing, and standards requirements
• Interacting with notified bodies, review labelling and marketing materials, and evaluate proposed device changes

Applicants must meet the following qualifications:

• 4+ years of experience in regulatory affairs
• Knowledge of U.S. FDA and EU MDR
• Experience preparing regulatory submissions
• Great communication skills