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