Philips Regulatory Affairs Manager 

Japan, Chiyoda 

716827757

Regulatory Affairs Manager

Regulatory Affairs Manager

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.

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

【就業時間】9:00-17:30休憩時間：原則として12:00-13:00

【休暇】初年度有給休暇最大20日間（2年度～5年度 20日／6年度以降 25日 付与）、CareLeave（年間10日間）、Sick

【その他】PhiliFlexポイント：72,000 ポイント（1ポイント＝1円）

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