Ddt Medical Device Investigation Analyst

Takeda UK

Bannockburn, IL, USA
Base: $89,900.00 - $141,240.00; bonus/equity: not ...
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Software medical device complaint handling
Fda quality system compliance
Root cause analysis
** The DDT Medical Device Investigation Analyst position at Takeda involves managing investigations related to software and connected medical devices, ensuring compliance with FDA requirements. The ideal candidate will have a background in medical device investigations and quality assurance, with a strong focus on documentation and cross-functional collaboration. **

Job Summary

  • The DD&T US Medical Device Investigation Analyst is responsible for leading and documenting investigations related to Takeda developed & owned software and connected medical devices.
  • This role ensures that device related complaints, incidents, and quality events are investigated in a timely, compliant, and inspection ready manner, supporting FDA Quality System and Medical Device Reporting (MDR) requirements.
  • Partner cross-functionally with Support, Product, and US based Regulatory and Quality teams to guide investigations and drive timely, compliant resolution.

Matching Summary

Match Score: 75

** The DDT Medical Device Investigation Analyst position at Takeda involves managing investigations related to software and connected medical devices, ensuring compliance with FDA requirements. The ideal candidate will have a background in medical device investigations and quality assurance, with a strong focus on documentation and cross-functional collaboration. **

Salary

Base: $89,900.00 - $141,240.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision insurance, 401(k) plan and company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays, well-being benefits, sick time, paid vacation

Skills & Requirements

Must-have

  • Software medical device complaint handling
  • FDA Quality System compliance
  • Root cause analysis
  • Medical Device Reporting (MDR)
  • TrackWise documentation

Nice-to-have

  • AI and advanced reporting
  • Cross-functional collaboration
  • Continuous improvement

Key Requirements

  • Bachelor's degree in Computer Science, Life Sciences, Quality, or related technical discipline
  • 2–5 years of experience in medical device investigations
  • Working knowledge of medical device quality system requirements
  • Experience performing root cause analysis
  • Basic knowledge of SQL and at least one programming language

Work Rights

Not specified

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