Philips Regulatory Affairs Senior Manager/Senior Principal 

Japan, Chiyoda 

483751209

Regulatory Affairs Senior Manager/Senior Principal

• 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.
• 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.

• +8 years’ experience in medical device regulatory affairs
• Actual experience of authoring active medical device SHONIN/NINSHO submission and received approval. (SaMD experience preferred)
• Maintains extensive knowledge of PMD act and Radio act.

• Capable of resolving escalated issues arising from day-to-day operation.

2. Skills.

• Self-motivated and able to prioritize to handle multiple tasks/responsibilities.
• Bachelor of Science Degree (Master 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）