Job Title:

Regulatory Affairs Senior Manager

About the Role:

We are seeking a highly experienced and skilled Regulatory Affairs Senior Manager to play an integral role in introducing new product/solutions, maintaining regulatory compliance, and leading transformation/improvement activities.

• Develop local regulatory strategy and lead strategic discussions with 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.
• Stay informed of new regulations such as mobile monitoring, clinical decision support, and AI.
• 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 documents.
• Proceed with regulatory assessments and promotional material reviews.
• Oversee product registration and RA administration activities.
• Drive various transformation/improvement activities.

Requirements:

• +10 years' experience in medical device regulatory affairs.
• Actual experience of authoring medical device SHONIN submission, including SaMD, and received approval.
• Maintains extensive knowledge of PMD act, ISO 13485, Radio act, and Measurement act.
• Experience or working knowledge of applicable standards/guidelines, including software development lifecycle, cybersecurity, clinical decision support in medical devices.
• Capable of resolving escalated issues arising from day-to-day operations.

• Self-motivated and able to prioritize to handle multiple tasks/responsibilities.
• Bachelor of Science Degree (Master preferred).
• Fluent in Japanese and English.

Benefits:

• Basic Salary: ¥950-¥1.4 million per year (dependent on experience).
• Incentive Pay: 20% of basic salary.
• Traffic Reimbursement.
• Social Insurance (Health Insurance, Pension Insurance) and Labor Insurance.
• Pension Plan and Stock Option Plan.
• On-the-job training and online courses.
• Career Development System and internal recruitment system.
• Philips Flex Points: 72,000 points (1 point = ¥1).