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Abbott

Makes heart devices, glucose sensors and lab tests

Regulatory Affairs Manager

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeTokyo, JapanNo salary listedIn-person

About the Job

Requirements

  • Bachelor's degree or higher.
  • At least 5 years of regulatory affairs experience in the medical device or in vitro diagnostic industry.
  • Experience leading an in vitro diagnostic approval application project.
  • Experience negotiating with PMDA and the Ministry of Health, Labour and Welfare.
  • Experience leading cross-functional teams.
  • Advanced knowledge of the Pharmaceuticals and Medical Devices Act and related regulations.
  • Expertise in in vitro diagnostics and molecular diagnostics.
  • Ability to develop regulatory strategies.
  • Project management ability.
  • Cross-organizational influence and leadership.
  • Problem-solving and decision-making ability.
  • Approximately TOEIC 700 proficiency.
  • Experience negotiating and presenting with global headquarters.
  • Ability to review and prepare English regulatory documents.

Responsibilities

  • Develop and execute regulatory strategies for the Molecular Division.
  • Develop regulatory strategies for new product introductions and expansion of existing products.
  • Develop integrated regulatory and market-access strategies encompassing approval and insurance coverage.
  • Analyze regulatory risks and opportunities and make recommendations to domestic and international executives and business units.
  • Support business plans, product portfolios, and launch plans from a regulatory perspective.
  • Assess business impacts of domestic and international regulatory and policy changes and develop responses.
  • Create business opportunities through relationships with relevant academic societies, industry associations, and government agencies.
  • Monitor regulatory and market-access trends in molecular diagnostics and companion diagnostics and reflect them in business strategy.
  • Oversee approval application, certification, and notification strategies for new products.
  • Lead negotiations as the primary contact with PMDA and the Ministry of Health, Labour and Welfare.
  • Lead PMDA face-to-face consultations, other consultations, and responses to inquiries.
  • Manage projects through product approval.
  • Develop and execute insurance coverage and reimbursement strategies.
  • Lead negotiations concerning insurance listing and reimbursement in collaboration with the Ministry of Health, Labour and Welfare, relevant academic societies, and internal stakeholders.
  • Develop market-launch plans integrating approval and reimbursement strategies.
  • Develop and advance clinical and analytical evidence strategies needed for insurance coverage.
  • Consult and negotiate with authorities on administrative notices, relevant laws, and regulatory requirements.
  • Coordinate regulatory strategies with pharmaceutical development partners for companion diagnostics.
  • Develop regulatory strategies to maintain approvals and maximize product value.
  • Oversee partial-change approval applications, minor-change notifications, and other change-control activities.
  • Review and approve electronic package inserts, labeling, instructions for use, and promotional materials from a regulatory perspective.
  • Develop regulatory strategies for indication expansions, additional indications, and new technology introductions.
  • Manage regulatory risks across the product lifecycle.
  • Address approval conditions, post-market requirements, and related regulatory obligations.
  • Oversee strategies for registration and maintenance of overseas manufacturers.
  • Oversee responses to quality management system conformity inspections.
  • Strengthen collaboration with quality assurance and overseas manufacturing sites.
  • Ensure alignment with global quality and regulatory requirements.
  • Manage and develop the regulatory team.
  • Set and evaluate team members’ goals and provide coaching.
  • Advance succession planning and organizational capability development.
  • Lead operational efficiency and continuous-improvement activities.
  • Promote collaboration with domestic and international stakeholders.
  • Participate in key projects as the regulatory representative.
  • Provide strategic support to marketing and sales.
  • Introduce best practices through collaboration with the global regulatory organization.

Desired Qualifications

  • Experience managing regulatory affairs in molecular diagnostics.
  • Experience obtaining approvals for companion diagnostics.
  • Experience leading PMDA face-to-face consultations.
  • Experience contributing to insurance or reimbursement strategies.
  • Quality assurance or clinical affairs experience.
  • Global team management experience.
  • Completion of management training.

About the Company

Abbott

Makes heart devices, glucose sensors and lab tests

Abbott makes medical devices, diagnostic tests, nutrition products and branded generic drugs for hospitals, laboratories, pharmacies and patients. Its best-known product is the FreeStyle Libre, a coin-sized sensor worn on the upper arm that tracks blood sugar around the clock without routine finger pricks. Its other lines run from heart valves, pacemakers and brain stimulators to lab analyzers, rapid tests and mail-in colon cancer screening kits, and Abbott earns money by selling these products to health systems, labs, retailers and consumers. The company was founded in 1888 by Chicago physician Wallace Abbott and is based in Abbott Park, Illinois.

Company size
10,001+
Company stage
IPO
Headquarters
Abbott Park, IL
Founded
1888

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