Philips Regulatory Affairs Manager 

Japan, Chiyoda 

577562342

Regulatory Affairs Manager

Regulatory Affairs Manager
Your role:

in introducing new product/solution, maintain regulatory compliance and leading transformation/improvement activities.

• 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.

You're the right fit if:

1. Experience.

• +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.

2. Skills.

• 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

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 .
• Discover .
• Learn more about .