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About the Role

This position is responsible for new product introductions and maintaining regulatory compliance for existing products in Philips' medical device business, specifically in the Hospital Patient Monitoring (HPM) and Sleep & Respiratory Care (SRC) areas. The role also involves driving process improvements and business transformation using AI, leading change initiatives that impact Patient Safety & Quality (PSQ) globally. We expect the candidate to contribute to both business growth and compliance through their regulatory expertise, cross-organizational collaboration, and leadership.

Responsibilities

Develop domestic regulatory strategies and lead strategic discussions with stakeholders to ensure compliance throughout the product lifecycle.
Proactively identify regulatory risks related to strategy, development plans, and products, proposing appropriate alternatives.
Interpret domestic regulatory requirements and provide expert advice to overseas design teams.
Prepare and review regulatory submission documents to advance approval processes.
Manage and maintain approvals for existing products.
Oversee regulatory affairs tasks including QMS/FMR registration, regulatory assessments, and promotional material reviews.
Liaise with and build strong relationships with the Ministry of Health, Labour and Welfare, Pharmaceuticals and Medical Devices Agency, and certification bodies.
Collaborate with PMS and Quality Assurance teams to address regulatory issues and drive ongoing compliance activities.
Promote operational efficiency and process improvements using AI and digital technologies.
Lead business transformation projects impacting PSQ globally in collaboration with international teams.
Contribute to the development of team members and enhancement of organizational capabilities.

Requirements

Work experience in the medical device industry.
Practical experience in preparing and obtaining approval for medical device applications.
Knowledge of the Pharmaceuticals and Medical Devices Act (Japan).
Experience participating in or leading global projects.
Business proficiency in both Japanese and English.
Regulatory affairs experience with SaMD (Software as a Medical Device).
Knowledge of the Radio Act and the Measurement Act (Japan).
Experience in business improvement projects utilizing AI and digital technologies.

Skills

Ability to prioritize and manage multiple tasks with a high degree of initiative.
Excellent analytical and problem-solving skills.
Strong communication skills for smooth collaboration with diverse stakeholders.
Ability to embrace change and drive business transformation.

Location

Head Office (Azabudai Hills)

Work Type

Hybrid (3 days in office, up to 2 days remote)

Experience Level

Manager

Education Level

Bachelor's degree or higher (Master's degree preferred)

Salary/Compensations

¥7,500,000 - ¥12,000,000

Benefits

Commuting allowance
Social insurance (Employees' Pension, Health Insurance) and Labor insurance (Employment Insurance, Workers' Compensation Insurance)
Retirement plan (lump sum and defined contribution pension)
Various online training and post-hire support training
Internal application system for career changes
PhiliFlex points (¥72,000)

About the Company

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.

Equal Opportunity

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.