|部署・役職名||Regulatory Affairs Manager – Device and IVD（CDx）|
Medical Device, Companion Diagnostics, and Preclinical Regulatory Gr builds and leverages medical device, combination product and IVD/CDx capabilities continuously to meet business objectives and compliance needs.
・This role is a representative of medical device and IVD/CDx regulatory affairs in Japan and carries out device regulatory affairs and necessary IVD（CDx） regulatory in combination drug development.
・For Device Regulatory Affairs, in cooperation with global team, perform a series of application tasks such as PMDA consultation for device part, preparation of CTD, response to inquiries, etc., also, establish of regulatory strategy for LCM, planning of application, application, approval acquisition, etc.
・For CDx Regulatory Affairs, in line with global development strategy, build CDx regulatory strategy in Japan with identifying and reducing risks, and also lead development communication with partner companies by collaborating with Clinical Biomarkers ＆ Diagnostics team （CBD）.
・Development and implementation of regulatory strategy in Japan for the medical device part of combination product development based on global strategy
・Preparation of CTD related to medical devices for combination products and handling of inquiries （RTQ）
・Identification of regulatory risks, and planning and implementation of PMDA consultations
・Device regulatory strategies in accordance with Device Life Cycle Management （LCM）, coordination with each department, PMDA consultation, Partial Change Application, Approval acquisition, submission of minor change notification, etc.
・Regulatory impact assessment for changes
・Regulatory conformity assessment and compliance check of medical devices related to development
・Development of Regulatory Strategy for CDx/IVD in Japan based on global development strategy
・Preparation support of CTD and handling of inquiries （RTQ） related to CDx/IVD with CBD
・Identifying potential risks, and planning and implementation of PMDA consultations to reduce and resolve them
・Collaboration with partner development companies and lead the communication between company and company by collaborating with CBD
・Actively inputs latest CDx/IVD regulations to JAPAC/Global CDx/IVD RA team
【必須（MUST）】・General knowledge on pharmaceutical science, development, regulatory, and
・ Regulatory principles of Medical Device and IVD/CDx
・Knowledge and understanding of the Pharmaceutical Affairs Law and related MHLW notifications
・Working with policies, procedures and SOP’s
・Knowledge of national legislation and regulations relating to devices/IVD
・Awareness of the registration procedures in region for marketing approval, post
・Managing and maintaining post－marketing regulatory activities of devices/IVD
【歓迎（WANT）】・Over 10 years experiences in Regulatory or Development of pharmaceutical, medical device or IVD industry including at least 5 years experiences in regulatory affairs with experiences conducting PMDA consultations, Device/IVD NDA, and obtaining approval in Japan
・Ability to build regulatory strategies. Identifying potential risks and make solution or mitigation plan by applying analytical skills to evaluate and interpret complex situations/problems using multiple sources of information
・Work in matrix environments including global teams under global environment
・Being open attitude
・Being positive about changes and challenges
・Actively and agilely learn things you do not know and catch up
・Work effectively in regulatory and cross－functional teams and deliver result even in uncertain condition
・Exercise leadership with interpersonal skills, be aware of stakeholder management, involve people, and work as a team
・Organizational, communication and time management skills needed to manage multiple