Job Information
Philips Regulatory Affairs Senior Manager - Japan in Tokyo, Japan
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】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）本社（麻布台ヒルズ） （変更の範囲）会社の定める就業場所
【就業時間】9:00-17:30 休憩時間：原則として12:00-13:00
【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）
【休日】毎週土曜日（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】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 Leave（年間最大30日間）ほか
【時間外労働】あり
※ただし、管理職での採用の場合は、残業代は支給対象外（深夜勤務手当、休日深夜勤務手当の支給はあり）
【給与】基本給 年収950～1400万円 ご経験により考慮します
【賞与】インセンティブ 20%
※インセンティブは毎年3月に支給。（会社業績、部門業績、個人評価によって変動あり）
※年度途中入社者は対象期間中日割計算あり
【手当】通勤手当の支給あり
【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）
【退職金制度】退職一時金および確定拠出年金の2本立て
【研修制度】 各種オンライン研修、入社後のサポート研修あり
【社内公募制度あり】社内でのキャリアチェンジを推進する制度として社内公募制度の体制あり
【その他】PhiliFlexポイント：72,000 ポイント（1ポイント＝1円）
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 .