Regulatory Affairs Manager

Job Summary

A company is looking for a Regulatory Affairs Manager.

Key Responsibilities

• Lead regulatory activities including 510(k), pre-submissions, and De Novo filings, ensuring compliance with FDA regulations
• Oversee the electronic Quality Management System (eQMS), including audits and CAPA management
• Monitor regulatory changes and provide actionable guidance to internal teams

Required Qualifications

• Bachelor's degree in Engineering, Science, or a related field (advanced degree preferred)
• 3-5+ years of regulatory affairs experience in medical devices, SaMD, or a similar environment
• Experience with eSTAR, eQMS platforms, and FDA submission processes
• Knowledge of cybersecurity frameworks and regulatory compliance best practices
• Strong project management skills with the ability to manage multiple priorities