Software Medical Device Investigator — Regulatory Compliance

Takeda; Exton (PA); On-site; USD 90,000 - 141,000; Full time

Job summary

Takeda in Bannockburn, IL / Exton, PA currently seeks a DD&T US Medical Device Investigation Analyst to lead investigations related to software devices used within PDT and BioLife operations in the US. You will coordinate FDA QSR and MDR-compliant investigations and prepare defensible records for inspections.

Working with Quality, Medical Affairs, and Operations, you will identify root causes, link to MDRs and CAPAs, and drive timely, compliant resolutions while documenting findings in TrackWise

Qualifications

• Bachelor's degree in computer science, Life Sciences, Quality, or 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.

Responsibilities

• Manage end-to-end software medical device complaint intake, investigation, and closure, ensuring FDA/QMS compliance and on-time processing.
• Triage issues (including ServiceNow IT tickets) 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, inspection-ready records.
• Reproduce defects in qualified environments and analyzed application code, system logs, database data, and release artifacts to identify probable root cause.
• 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.
• Author clear, concise complaint narratives in TrackWise, preserving reporter intent and supporting conclusions with complete evidence.
• Partner cross-functionally with Support, Product, and US based Regulatory and Quality teams to guide investigations and drive timely, compliant resolution.
• Create, review, and develop mitigation process and procedures for all identified complaints that have compliance risk without an immediate final resolution.
• Support MDR reportability assessments by providing investigation findings, timelines, and technical input in accordance with FDA 21 CFR Part 803 requirements for software devices.
• Participate in audit responses related to device investigations, complaints, and MDR activities. Participate in-person for all US based audits.
• Identify trends and contribute to continuous improvement of investigation processes and metrics.
• Provide required reporting on all DDT-related compliance activities including Complaint and quality record timeliness and department training.
• Work cross-functionally to incorporate AI and advanced reporting into all DDT compliance activities.
• Ensure all DDT teams are adequately training on quality related compliance activities.

Skills

SQL

Programming language

Cross-functional communication

Investigation ownership

Education

Bachelor's degree in computer science

Tools

Power BI

TrackWise

Job description

Takeda in Bannockburn, IL / Exton, PA currently seeks a DD&T US Medical Device Investigation Analyst to lead investigations related to software devices used within PDT and BioLife operations in the US. You will coordinate FDA QSR and MDR-compliant investigations and prepare defensible records for inspections.

Working with Quality, Medical Affairs, and Operations, you will identify root causes, link to MDRs and CAPAs, and drive timely, compliant resolutions while documenting findings in TrackWise