Regulatory Affairs Associate

Job Summary

Assisting in the preparation of regulatory submissions for in vitro diagnostic devices, the full-time Regulatory Affairs Associate will work remotely to maintain FDA submission files, coordinate documentation, and support compliance with regulatory standards.

Key Responsibilities

• Assists in writing and implementing process improvements for Regulatory Affairs functions
• Maintains regulatory document filing and retrieval in accordance with SOPs
• Compiles and formats materials required for submissions and license applications

Required Qualifications

• Bachelor's Degree
• 2+ years of experience in regulatory affairs within the diagnostic or pharmaceutical industry
• Knowledge of FDA guidelines and quality systems regulations (QSRs)
• Experience with IVDs, molecular diagnostics, or PCR-based assays