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Regulatory Affairs Senior Manager

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it’s not just what we do, it’s who we are. We are 75,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers’ needs. It’s what inspires us to create meaningful solutions – the kind that make a real difference – when it matters most.

The world and our customers’ needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That’s why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

Your role:

Exciting opportunity to lead Cardiac and Endovascular projects of Philips Image-guided Therapy, including novel technologies integrated by therapeutic devices and visualization systems.

• Develop local regulatory strategy and lead the strategic discussion with related stakeholders, including Business Unit, R&D, Clinical Affairs, and Market Access & Reimbursement to accelerate projects and fast serve patients.

• 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 and technologies relevant to endovascular therapeutics.

• 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.

You're the right fit if:

1. Experience.

• +10 years’ experience in medical device regulatory affairs

• Actual experience of authoring Class III/IV medical device SHONIN submission in EVT or relevant devices and received approval.

• Maintains extensive knowledge of PMD act, ISO 13485.

• Experience or working knowledge of active medical devices and imaging technologies.

• 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

募集要項：

【契約期間】期間の定めなし

【試用期間】あり(原則として入社日より6ヶ月)

【業務内容】（雇入れ直後）上記のとおり（変更の範囲）会社の定める業務

【就業場所】（雇入れ直後）麻布台本社　（変更の範囲）会社の定める就業場所

【勤務形態】ハイブリット（週3日オフィス出社、週2日までリモート勤務可能）

【就業時間】9:00-17:30

【休憩時間】原則として12:00-13:00

【休日】毎週土(所定休日)/日曜日(法定休日)、国民の祝日、年末年始(12月29日-1月4日)

【休暇】 有給休暇 (初年度最大20日間(初年度は入社月で変動)、Care Leave(年間10日間付与)、Sick Leave(年間30日間付与)ほか

【給与】能力/ご経験を考慮して優遇します

【手当】通勤手当の支給あり

【インセンティブ制度】アニュアルインセンティブ※年度途中入社者は勤務期間による案分あり

【加入保険】社会保険(厚生年金保険、健康保険)・労働保険(雇用保険、労災保険)　

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 .