【COMPANY OVERVIEW】
A well-known medical device company setting up in Japan, specializing in surgical robot.
【JOB RESPONSIBILITIES】
You will play a key role in regulatory affairs and QMS of the company
Compile and maintain documentation to support local submissions
Provide regulatory and quality support to MAHs
Support the development and implementation of the local regulatory strategies
Support the implementation of the global Quality Management System
Maintain regulatory and quality expertise in the evolving regulatory environment
【WHY YOU SHOULD APPLY】
Huge exposure to RA/QMS activities in Life Sciences industry
Chance to be a part of a rapidly growing company
Advanced surgical technology
【REQUIREMENTS】
A 4-year college degree
A minimum of 1 year of medical device Regulatory Affairs experience
A solid knowledge of PMDA regulations and Quality System regulations (ISO 13485 and 21CFR)
Fluent in Japanese and English
【FOR FURTHER INFORMATION】
Click apply
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