- 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.
- 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/Author product registration document and reimbursement document.
- Proceed regulatory assessment and promotional material review.
- Supervise RA administration activities.
- Lead various transformation/improvement activities.
- +7 years' experience in medical device regulatory affairs
- Maintains general knowledge of PMD act, ISO 13485, Radio act.
- Actual experience of authoring class III / IV medical device submission including SaMD and received approval.
- Self-motivated and able to prioritize to handle multiple tasks/responsibilities.
- Bachelor of Science Degree in a technical discipline (Master's preferred)
- Fluent in Japanese and English
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説明
Job Title
Regulatory Affairs ManagerJob Description
Job title:
Regulatory Affairs Manager
Your role:
Exciting opportunity to play an integral role in introducing new product/solution, maintain regulatory compliance and leading transformation/improvement activities.
You're the right fit if:
1. Experience.
2. Skills.
About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
