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Philips Regulatory Affairs Senior Manager 
Japan, Chiyoda 
308419972

24.06.2024
Regulatory Affairs Senior Manager
  • Develop local regulatory strategy and lead the strategic discussion with related stakeholders to accelerate project development.
  • Proactively identify risks within regulatory strategies, plans, products and propose alternate approaches.
  • Provide interpretation of local regulations to BU partners and ensure necessary requirements are fully deployed.
  • Stay informed of new regulations such as mobile monitoring, clinical decision support and AI.
  • Plan and execute product registration aligned with local business needs.
  • Maintain current registration approvals accordingly.
  • Manage interactions with MHLW/PMDA and maintain a productive working relationship.
  • Review and Author product registration/reimbursement document.
  • Proceed regulatory assessment and promotional material review.
  • Oversee product registration and RA administration activities.
  • Drive various transformation/improvement activities.
  • +10 years’ experience in medical device regulatory affairs
  • Actual experience of authoring medical device SHONIN submission including SaMD and received approval.
  • Maintains extensive knowledge of PMD act, ISO 13485, Radio act and Measurement act.
  • Experience or working knowledge of applicable standards/guidelines including software development lifecycle, cybersecurity, clinical decision support in medical device.
  • Capable of resolving escalated issues arising from day-to-day operation.
2. Skills.
  • Self-motivated and able to prioritize to handle multiple tasks/responsibilities.
  • Bachelor of Science Degree (Master preferred)
  • Fluent in Japanese and English