- Establish local regulatory strategy and engage in strategic discussions with relevant stakeholders to expedite projects and efficiently cater to patients.
- Identify potential risks in regulatory strategies, plans, and products, and suggest alternative solutions.
- Interpret local regulations to Business Unit partners and ensure compliance with necessary requirements.
- Keep abreast of new regulations and technologies related to endovascular therapeutics.
- Manage product registration in alignment with local business needs.
- Maintain current registration approvals as required.
- Handle interactions with MHLW/PMDA and nurture a positive working relationship.
- Review and draft product registration/reimbursement documentation.
- Conduct regulatory assessments and review promotional materials.
- Supervise product registration and regulatory administration tasks.
- Lead various transformation and improvement initiatives.
- +7 years' experience in medical device regulatory affairs
- Prior experience in authoring Class III/IV medical device SHONIN submissions in EVT or related devices, and obtaining approvals.
- In-depth knowledge of PMD act and ISO 13485.
- Familiarity with active medical devices and imaging technologies.
- Skilled in resolving escalated operational issues.
- Self-motivated with excellent prioritization skills for managing multiple tasks.
- Strong critical, logical, and strategic thinking abilities.
- Bachelor of Science degree (Master's preferred).
- Proficient in Japanese and English.
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説明
Job Title: Regulatory Affairs Senior Specialist
Job Description:
Philips is a leading company in health technology, focused on improving countless lives globally and working towards a healthier and more sustainable world through innovation. Guided by the vision of a brighter future.
But it's not just what we do, it's who we are. We are a team of 75,000 unique individuals, united by a strong sense of purpose and a relentless drive to meet our customers' needs. This is what motivates us to develop impactful solutions - ones that truly make a difference - especially when it's most needed.
The world and our customers' needs are evolving rapidly, and while we take pride in our current efforts, we believe there's always room for improvement. That's why we're looking for someone like you, to help us address the increasingly complex challenges brought on by the changing landscape of health and well-being.
Your Role:
Exciting opportunity to oversee Cardiac and Endovascular projects within Philips Image-guided Therapy, involving cutting-edge technologies integrated into therapeutic devices and visualization systems.
You're a Great Match If:
1. Experience:
2. Skills:
About Philips:
As a healthcare technology firm, we are dedicated to the belief that every individual's health is important, and we won't rest until quality healthcare is accessible to all. Join us in making a meaningful impact on the lives of others.
