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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 used in US PDT and BioLife operations. 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.

The specialist works closely with DD&T, Quality, Medical Affairs, and Operations to identify root cause, assess patient and donor risk, and ensure appropriate linkage to MDR, Deviation, CAPA, and continuous improvement activities.

Responsibilities Include:

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.

Required 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.

Strong written documentation and crossfunctional communication skills.

Basic knowledge of SQL and at least one programming language.

Preferred Qualifications:

Experience with software as a medical device (SaMD) or digital health platforms.

Familiarity with FDA MDR (21 CFR Part 803) and postmarket surveillance support activities.

Experience working in plasma collection, biotech, or highly regulated operational environments.

Prior support of FDA inspections or quality audits.

Experience with Power BI (including building reports and dashboards).

Key Competencies:

Investigation ownership and critical thinking

Riskbased decision making

Highquality technical documentation

Crossfunctional collaboration in regulated environments

Regulatory and compliance mindset.

Working Conditions:

Hybrid office/remote environment

May require flexibility to support investigation timelines tied to regulatory reporting commitments and major incidents

Requires US time zone availability for in person US audit support and collaboration with US based BioLife, regulatory, medical affairs, compliance, and operations.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Job Exempt