Safety Control & RA Manager, Japan

Safety Control & RA Manager, Japan job description: oversee post-market safety management activities, manage regulatory affairs for medical devices in Japan, and ensure compliance with Japanese legislation and global procedures. The role also serves as the primary regulatory contact for Japan and collaborates closely with global cross-functional teams.

Requirements

• Bachelor's degree in physics, chemistry, biology, engineering, or relevant field
• Experience in post-marketing safety management of medical devices for 3 or more years (Class 3 and Class 4)
• Minimum 3 years experience in regulatory affairs, quality control operations, or similar operations in the medical device industry
• Knowledge of relevant Japanese regulations such as PMD Act, MHLW Ministerial Ordinance #169 and #135, and international standards (i.e. ISO13485)
• Japanese (native level) and English (business level)
• PC-Skills: Outlook, Word, Excel, PowerPoint

Benefits

• Extended Health Benefits