SaMD and IVD Principal Manager
Takeda Pharmaceutical Company(1 month ago)
Lexington, MAOnsiteFull TimeManager$111,800 - $175,670Device Quality
Apply NowAbout this role
The SaMD and IVD Principal Manager at Takeda is an experienced quality and technical professional within the Device Quality function, focused on ensuring product quality and regulatory compliance for software medical devices, in vitro diagnostics, and combination products. The position supports products across the lifecycle, from development through commercialization and post-market activities. The role is based in Lexington, MA.
Required Skills
- Risk Management
- Quality Assurance
- Regulatory Compliance
- Software Validation
- IEC 62304
- ISO 13485
- CAPA
- Change Control
- Supplier Qualification
- Root Cause Analysis
+1 more
Qualifications
- Bachelor's Degree in Engineering
- Advanced Degree (Preferred)
About Takeda Pharmaceutical Company
takeda.comTakeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.
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