SaMD & Medical Device Investigation Analyst

Takeda; Bannockburn (IL); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda is seeking an experienced DD&T US Medical Device Investigation Analyst to lead and document investigations of software-driven medical devices used in U.S. PDT and BioLife operations.

You will ensure FDA QSR/MDR compliance, tie investigations to MDRs, CAPAs, and change controls, and drive timely, inspection-ready records. Collaborating with Quality, Medical Affairs, and Operations, you will perform root-cause analyses, link issues to releases, and create clear narratives in TrackWise,

Qualifications

• Bachelor’s degree in computer science, life sciences, quality, or a closely related technical discipline.
• 2–5 years of experience in medical device investigations, quality assurance, complaint handling, or regulated IT/healthcare environments.
• Working knowledge of medical device quality system requirements (FDA QSR, ISO 13485 concepts).
• Experience performing root cause analysis and documenting regulated investigations.
• Strong written documentation and cross-functional communication skills.
• Basic knowledge of SQL and at least one programming language.

Responsibilities

• Manage end-to-end software medical device complaint intake, investigation, and closure, ensuring FDA/QMS compliance and on-time processing.
• Triage issues to determine complaint applicability, regulatory impact, and donor safety, eligibility, and data integrity risk.
• Execute FDA-ready investigations proportional to complaint significance, producing complete, defensible records.
• Document root cause or most probable cause with objective evidence and clear rationale when definitive conclusions were not possible.
• Link complaints to releases, builds, and change controls, ensuring full traceability across quality records.

Skills

Root cause analysis

Cross-functional collaboration

Regulatory and compliance mindset

Strong written communication

Critical thinking

Education

Bachelor’s degree in computer science, Life Sciences, Quality, or related

Tools

Power BI

SQL

Job description

Takeda is seeking an experienced DD&T US Medical Device Investigation Analyst to lead and document investigations of software-driven medical devices used in U.S. PDT and BioLife operations.

You will ensure FDA QSR/MDR compliance, tie investigations to MDRs, CAPAs, and change controls, and drive timely, inspection-ready records. Collaborating with Quality, Medical Affairs, and Operations, you will perform root-cause analyses, link issues to releases, and create clear narratives in TrackWise,