Medical Device Risk Management Advisor

Job Summary

A company is looking for a Medical Device Risk Management Advisor (Part-Time, Remote).

Key Responsibilities

• Test new features and prototypes periodically
• Provide feedback on usability and regulatory alignment
• Review risk management and documentation workflows

Required Qualifications

• Experience in medical device regulatory affairs or quality assurance
• Familiarity with ISO 14971 risk management
• Knowledge of design controls and DHF documentation
• Experience with 510(k), De Novo, or PMA processes is a plus
• Background in risk management file, FMEA, or hazard analysis