Medical Devices Regulatory Affairs Specialist

Johnson & Johnson (Chiyoda, 日本) 16日前

• New product registration related work (PMDA consultation, application for approval, application for certification, notification)

  • Input local requirements to the design owner located in foreign countries.
  • Collect all necessary information/data for the product registration from the design owner, etc.
  • Establish robust and various regulatory strategy
  • Execute regulatory strategy flawlessly
  • Provides solutions to a variety of problems

• Change management work to maintain the registration files.
• All other operations and administrative response related to regulatory compliance based on the Pharmaceutical and Medical Device Act
• Review the promotional materials
• Lead the project to improve working environment and/or internal process


Qualifications

Education:
• Bachelor’s degree or higher.
Experience and Skills:
• English – business level (TOEIC 800 or above)
• Work experience as regulatory affairs specialist in the medical device industry
• Deep knowledge of PMD Act and high compliance awareness
• Logical thinking
• Strong communication skill

Preferred:
• Work experience in submitting the registration file with clinical data
• Work experience in submitting the registration file for the product developed in foreign country
• Take an action proactively
• Global mindset
• Build good relationship with various stakeholders
Other:
• Travel (local/global) percentage: less than 10%


Primary Location
Japan-Tokyo-To-Chiyoda-
Organization
Johnson & Johnson K.K. (8235)
Job Function
Regulatory Affairs
Requisition ID
2105914682W

Medical Devices Regulatory Affairs Specialist

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