・Support Quality Assurance supervisor to achieve Japan Commercial Operations objectives from Medical device perspective
・When Quality Assurance issue arises, lead to define the appropriate Quality measurement through the communication with the related internal, global and external parties.
・Ensure full compliance with applicable regulations in Japan.
・Oversee all activities or responsibilities that are delegated to external parties.
＜Desired Education, Skills and Experience＞
・5+years Knowledge of relevant in Quality Assurance in Medical Device industry. ・Experience of managing Medical Device class2 or3
・Experience of complaint handling
・Experience in both clinical and post-marketing environment.
・Understanding of PMD Act, relevant regulations and guidelines.
・Thorough knowledge of drug and medical device development process.
・Very good communication and problem solution skill among cross-functional team.
・Bachelor’s Degree in Science or related discipline
・Knowledge of relevant in Quality Assurance in pharma industry is plus.