Description

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, reg...