Regulatory Affairs Manager

Philips
Tokyo
Workplace: HybridFull timeJPY 7,500,000 - 12,000,000 annuallyFunction: Quality & Regulatory (Non-Software)Education: bachelorsSkills: ["Leadership","Communication","Analysis","Problem-solving","Prioritization"]

Lead regulatory affairs for medical device products across the full lifecycle, including defining domestic regulatory strategy, identifying regulatory risks, and managing approval submissions and authorization maintenance. Oversee QMS/FMR registration and regulatory reviews, coordinate with ministries and certification bodies, and partner with PMS (post-market surveillance) and quality teams. Drive AI- and digital-enabled process improvements and lead global PSQ transformation activities, including team development.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Philips
Philips
1 month ago

Regulatory Affairs Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 31 days agoStatus: Live

Job Summary

Lead regulatory affairs for medical device products across the full lifecycle, including defining domestic regulatory strategy, identifying regulatory risks, and managing approval submissions and authorization maintenance. Oversee QMS/FMR registration and regulatory reviews, coordinate with ministries and certification bodies, and partner with PMS (post-market surveillance) and quality teams. Drive AI- and digital-enabled process improvements and lead global PSQ transformation activities, including team development.
Location: Tokyo
Workplace: Hybrid
Employment Type: Full time
Job Function: Quality & Regulatory (Non-Software)
Seniority: Manager level

Key Responsibilities

  • •Develop domestic regulatory strategy to ensure compliance across the product lifecycle and lead strategic discussions with stakeholders.
  • •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 teams.
  • •Prepare and review regulatory submission documents to drive approval applications, and manage authorization maintenance for existing products.
  • •Oversee regulatory management activities such as QMS/FMR registrations, regulatory evaluations, and promotional material reviews, while coordinating with PMS and quality teams and leading PSQ transformation projects using AI/digital process improvements.

Pay and Benefits

Salary: JPY 7,500,000 - 12,000,000 annually
Perks:Health InsurancePensionPaid Leave

Key Requirements

  • •Work experience in the medical device industry.
  • •Practical experience preparing regulatory approval application documents and obtaining approvals for medical devices.
  • •Knowledge of the Pharmaceutical and Medical Device Act (医薬品医療機器等法).
  • •Experience participating in or leading global projects.
  • •Ability to perform work in Japanese and English.
Experience:Medical devicesHealthcarePost-market surveillance
Education:Bachelor's
Skills:LeadershipCommunicationAnalysisProblem-solvingPrioritization
Languages:JapaneseEnglish
Tech Stack:AIDigital technologyQMSPMS

Company Brief

Philips
Global health technology company focusing on diagnostic imaging, patient monitoring, and consumer health products. Philips develops medical devices, healthcare informatics, and solutions to improve patient care and personal well-being.
Industry: HealthTech
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Public Company
Valuation: Public Company (Market Cap in USD)
Funding: IPO / Publicly Listed
Headquarters: Amsterdam, Netherlands
Founded: 1891
Glassdoor
Glassdoor: 3.8
WebsiteLinkedIn