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Philips

Makes medical devices and personal health products

Regulatory Affairs Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeTokyo, Japan

About the Job

Requirements

  • Experience working in the medical-device industry.
  • Practical experience preparing medical-device approval applications and obtaining approvals.
  • Knowledge of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
  • Experience participating in or leading global projects.
  • Ability to conduct business in Japanese and English.
  • Ability to prioritize and execute multiple tasks independently.
  • Strong analytical and problem-solving ability.
  • Ability to collaborate effectively with diverse stakeholders.
  • Ability to promote business transformation and respond positively to change.
  • A bachelor's degree or higher is required.

Responsibilities

  • Develop domestic regulatory strategies to ensure compliance throughout the product lifecycle and lead strategic discussions with relevant stakeholders.
  • Proactively identify regulatory risks related to regulatory strategy, development plans, and products, and propose appropriate alternatives.
  • Interpret domestic regulatory requirements and provide regulatory advice to overseas design-origin teams.
  • Prepare and review regulatory submission documents and drive approval applications.
  • Maintain approvals for existing products.
  • Oversee regulatory administration, including QMS/FMR registrations, regulatory assessments, and promotional-material reviews.
  • Negotiate and build strong relationships with the Ministry of Health, Labour and Welfare, the Pharmaceuticals and Medical Devices Agency, and certification bodies.
  • Work with post-market surveillance and quality assurance teams to address regulatory issues and advance ongoing compliance activities.
  • Promote operational efficiency and process improvement using AI and digital technologies.
  • Collaborate with global teams and lead business-transformation projects affecting Patient Safety & Quality.
  • Develop team members and contribute to improving organizational capabilities.

Desired Qualifications

  • Regulatory affairs experience related to Software as a Medical Device.
  • Knowledge of the Radio Act and the Measurement Act.
  • Experience with business-improvement projects using AI and digital technologies.
  • A master's degree is welcomed.

About the Company

Philips

Makes medical devices and personal health products

Philips makes medical equipment and software for hospitals and care providers, along with personal health products for consumers. Its hospital portfolio spans MRI and CT scanners, ultrasound, image-guided treatment systems and patient monitors, while Sonicare and Avent cover oral health and baby care. Clinical software connects medical images and patient data across care teams, and the company earns revenue from equipment, software, maintenance and consumer product sales. It works with health systems through long-term technology and service partnerships, including solutions for care at home. Founded in 1891, Philips is headquartered in Amsterdam, the Netherlands.

Company size
10,001+
Company stage
Acquired
Total funding
$164.7M
Headquarters
Andover, MN
Founded
1891

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