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Job ID :
53211BR
Location :
Japan - Tokyo
:
Job Description

RESPONSIBILITES:

  • Handling the discussion and negotiation with PMDA, MHLW.
  • Handling the communication with headquarters (Uppsala, Freiburg).
  • Handling the communication with Internal Stakeholders.
  • Handling the statistical analysis of non-clinical and clinical data, preparation of data package.
  • Handling the submission for IVD/MD products and preparation of the documents/dossier.
  • Involving portfolio management activities for future products of TFD KK
  • Supporting QA activity of TFD KK, involve its Quality Management System and quality policy.

REQUIREMENTS / EDUCATION:

  • Must be pharmacist
  • Required language skills: Fluent in Japanese and business level in English (oral and written)
  • Must have an experience of Regulatory Affairs for In-Vitro Diagnostic/Medical Device for a minimum of 5 years.
  • Experiences of consultation, discussion and negotiation with PMDA through consultation, application for marketing approval and partial change approval.
  • Experiences of reimbursement process for clinical test, negotiation with MHLW.
  • Knowledge of Pharmaceuticals & Medical Devises Act., QMS ministerial ordinance.
  • Experiences of QA activities for In-Vitro Diagnostic/Medical Device. QMS compliance inspection, Internal Audit, Field Safety notice and Recall
  • Experiences of QMS supervisor is desired.


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