DDT Medical Device Investigation Analyst

Job description

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job 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-t...