Regulatory Affairs & QMS Specialist

Location
Job type Permanent
Salary 5,000,000 ~ 6,000,000 JPY
Reference 33671

【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

OR

  • Contact Jessica:

jessica.sanusi@cornerstone.jp