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Google Regulatory Affairs Specialist Google Health Japanese English 
Japan, Tokyo 
305194904

01.09.2024

Minimum qualifications:
  • Bachelor's degree in a scientific or engineering discipline (e.g., Biomedical Engineering, Life Sciences), or equivalent practical experience.
  • 5 years of experience in regulatory strategy within the Healthcare and Lifesciences specifically the medical device industry, with a focus on SaMD.
  • Ability to communicate in Japanese and English fluently to support client relationship management in this region.

Preferred qualifications:
  • Experience in successful submissions and approvals for SaMD products with the PMDA and MHLW.
  • Knowledge of Japanese medical device regulations, including those specific to SaMD.
  • Understanding of relevant Asia-Pacific regulations.
  • Excellent organizational, verbal and written communication skills to effectively communicate complex regulatory information to both technical and non-technical audiences.