|部署・役職名||Quality Regulatory Compliance Manager|
The position of Quality Regulatory Compliance is within our IDEM Business Unit located at our Chiba Plant, in Japan.
This role provide quality oversight and leadership by proposing and implementing process improvements and maintaining and improving various quality system processes. Conceive, plan, design, conduct and lead quality activities. Train others and advance the state of cGMP and compliance knowledge of the organization. Participate in strategy development, and translate strategy into specific actions. Assure projects are completed within time and compliantly. Establish department goals and plans to meet them. Makes independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures, aligned with the quality system and consistent with regulatory requirements and business objectives.
The position may functional areas such as Supplier Controls, CAPA and Complaint, Non Product Software Validation, Product ＆ Process Controls. The position will make independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the quality system and consistent with regulatory requirements and business objectives.
This job function has accountability for complying with the applicable elements of Global Quality and the Quality Management System （QMS）.
【必須（MUST）】・5 plus years in a regulated environment, preferably in medical devices with excellent understating and knowledge of quality system processes.
・Working experience of FDA’s 21 CFR Part 820 Quality System Regulation, ISO 13485:2016
Medical Devices, and ISO 14971:2012 Risk Management.
【歓迎（WANT）】・Advanced degree （MS/PhD） preferred
・Process Excellence certified （Green Belt / Black belt）.