Quality and Regulatory Manager

Що очікуємо

• 3+ years experience in quality management (ISO 13485 or ISO 9001);
• Proven track record working in a quality manager or regulatory affairs positions;
• Have a good understanding of ISO 13485 and ISO 14971;
• Understanding of Software as a Medical Device (SaMD), including lifecycle processes, documentation, and validation;
• Knowledge of emerging AI regulatory frameworks and ethical considerations;