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Philips Regulatory Affairs Senior Manager - IGTD 
Japan, Chiyoda 
637583477

24.06.2024
Regulatory Affairs Senior Manager - IGTD
  • Develop local regulatory strategy and lead the strategic discussion with related stakeholders, including Business Unit, R&D, Clinical Affairs, and Market Access & Reimbursement to accelerate projects and fast serve patients.
  • 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 and technologies relevant to endovascular therapeutics.
  • 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 productregistration/reimbursementdocument.
  • Proceed regulatory assessment and promotional material review.
  • Oversee product registration and RA administration activities.
  • Drive varioustransformation/improvementactivities.
  • +10 years’ experience in medical device regulatory affairs
  • Actual experience of authoring Class III/IV medical device SHONIN submission in EVT or relevant devices and received approval.
  • Maintains extensive knowledge of PMD act, ISO 13485.
  • Experience or working knowledge of active medical devices and imaging technologies.
  • Capable of resolving escalated issues arising from day-to-day operation.
2. Skills.
  • Self-motivated and able to prioritize to handle multipletasks/responsibilities.
  • Bachelor of Science Degree (Master preferred)
  • Fluent in Japanese and English