- 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.
- +7 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.
- Self-motivated and able to prioritize handling multiple tasks/responsibilities.
- Capable of thinking critically, logically, and strategically
- Bachelor of Science Degree (Master preferred)
- Fluent in Japanese and English
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説明
Job Title
Regulatory Affairs ManagerJob 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 lead Cardiac and Endovascular projects of Philips Image-guided Therapy, including novel technologies integrated by therapeutic devices and visualization systems.
You're the right fit if:
1. Experience.
2. Skills.
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.
