Regulatory Affairs Specialist II

2週間前

Tokyo Thermo Fisher Scientific Full time
:
  • Work with RA/QA team to maintain and handle regulatory licenses of IVD/MD/AH (MAH, FMA, etc.) under the PMD Act and perform QMS activities.
  • Responsible for GVP operations for Medical Device (MD) /IVD products/ Animal Health products(AH) in Life Technologies Japan.
  • Collaborate with cross functional discussion and issue management and close collaboration with Internal Stakeholders such as business teams, internal RAQA team, SCM and other related teams for GVP operation
  • Running the implementation of regulatory training (drafting annual plans, crafting training materials, implementing e-learning, crafting and storing records, etc.)
  • Management of promotional material reviews
  • Responding to inquiries from overseas bases and customers

    • Required qualifications and experience:

  • Minimum 1 year of experience in RAQA within the pharmaceuticals, medical devices, or in vitro diagnostics industry
  • Knowledge of Japanese regulatory requirements
  • English skills to connect with overseas parties (email correspondence)
  • Basic PC skills (Word, Excel (spreadsheets and graphs), PowerPoint)

    • Qualifications and experience encouraged

  • Experience responding to QMS conformity surveys and ISO13485 surveys by regulatory authorities or certification registration bodies
  • Experience in safety-related work
  • Experience using document management systems
  • Experience in the three roles of a manufacturing and sales company

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