Regulatory Affairs Senior Manager / Senior Principal

JOB DESCRIPTION

Job Title

Regulatory Affairs Senior Manager / Senior Principal

Job Description

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 play an integral role in introducing new product / solution, maintain regulatory compliance.

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.

You're the right fit if :

1. Experience.

• 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

6ヶ月）

9 : 00-17 : 30　休憩時間：原則として12 : 00-13 : 00

3日オフィス出社、週2日までリモート勤務可能）

12月29日-1月4日）

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

950～1400万円　ご経験により考慮します

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）

2本立て

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.

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 .