RA Specialist

6日前

Tokyo Thermo Fisher Scientific Full time
  • Develop and implement regulatory strategy across projects to ensure that company products are safe, legal and meet expectations with regulations.
  • Maintain and improve upon processes to ensure compliance with required regulatory standards and governing bodies.
  • Prepare documents for regulatory filing and agency consultation materials under PMD Act.
  • Maintain regulatory documents to keep registration status.
  • Manage clinical validation studies with clinical affairs
  • Represent the Regulatory Affairs function at multi-departmental meetings.
  • Liaise with competent authorities and notified bodies to seek advice and guidance.

    • How will you get here?

    Education and experience

  • Bachelor's degree or above for chemical, pharmaceutical, medical, science, etc.
  • Regulatory experience in the IVD or medical device industry

    • Knowledge, Skills, Abilities

  • Ability to plan multiple tasks and effectively prioritize activities
  • Effective communicator with internal customers
  • Proactive with proven ability to work under own initiative, and strong team player
  • Fluent in Japanese and business level in English (oral and written)
  • Excellent IT skills
  • Pharmacist license holder preferred

    • At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

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