医療機器の転職・仕事・業界完全ガイドのライフケア・ネットワークの【Regulatory Affairs Manager – Device and IVD(CDx)：SD-1534MY】

Job Summary
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).

＜Specific＞
・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