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Abbott

Makes heart devices, glucose sensors and lab tests

Safety Specialist

Regulatory & Quality (Life Sciences)Updated on Nov 12
Full-timeTokyo, JapanNo salary listedIn-person

About the Job

Requirements

  • University graduation or higher is required.
  • Basic computer skills in Excel, Word, and PowerPoint are required.
  • The candidate must be comfortable working with English-language documents and willing to learn.
  • Logical thinking ability is required.
  • Communication ability is required.

Responsibilities

  • Collect, review, evaluate, and report domestic safety cases to authorities.
  • Collect, review, evaluate, and report foreign safety cases and foreign safety measures to authorities.
  • Collect, review, evaluate, and report safety-management information from literature.
  • Confirm safety information with overseas manufacturers and respond to inquiries.
  • Receive complaint and defect information, verify its contents, and coordinate with related departments.
  • Support preparation of customer letters and safety-information documents.
  • Review and revise package inserts and related documents.
  • Participate in risk assessments before product introduction.
  • Support implementation of safety measures.
  • Analyze trends in defect information and manage related data.
  • Participate in tasks related to post-market surveillance studies.
  • Coordinate with related departments.
  • Participate in business process improvement activities.
  • Perform post-market safety management for assigned product groups.
  • Conduct safety evaluations and risk-management activities throughout the product lifecycle.
  • Coordinate with domestic and international departments and manufacturers.

Desired Qualifications

  • Experience in the medical-device, pharmaceutical, or healthcare industry is preferred.
  • Experience in quality assurance, regulatory affairs, clinical research associate or clinical research coordinator work, post-market surveillance, or safety management is preferred.
  • Experience handling email in English is preferred; a TOEIC score of approximately 650 is noted.
  • Data analysis experience is preferred.
  • Knowledge of good vigilance practice, quality management systems, or Japan's Pharmaceuticals and Medical Devices Act is preferred.
  • Qualifications such as registered nurse, medical technologist, or clinical engineer are preferred.

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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