Job Description: 

Knowledge of medical regulations including FDA, EU MDR, NMPA/CFDA, and other applicable international regulations
Knowledge of regulatory standards such as IEC 60601, ISO13485, 14971 and other applicable standards and substandard.
Proficiency in interpreting, applying complex regulations, and preparing associated documentation.
Excellent interpersonal communication and collaboration skills
Bachelor’s degree in engineering, Science or related area
Minimum of 2 years of experience working with medical devices regulations and quality management system.