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Philips Regulatory Affairs Senior Manager Japan, Chiyoda 308419972
24.06.2024
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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.
- Self-motivated and able to prioritize to handle multiple tasks/responsibilities.
- Bachelor of Science Degree (Master preferred)
- Fluent in Japanese and English
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