Takeda · 2 days ago
SaMD and IVD Principal Manager
Lexington, MA
Full-time
Onsite
Senior Level, Lead/Staff
$112K/yr - $176K/yr
5+ years expTakeda is a company focused on delivering innovative medicines and therapies. They are seeking a SaMD and IVD Principal Manager who will be responsible for executing activities within the Device Quality function to support software medical devices and in vitro diagnostics, ensuring compliance with quality and regulatory standards throughout the product lifecycle.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Executing activities within the Device Quality (DQ) function to support software medical devices (SaMD), in vitro diagnostics (IVD), and combination products across all phases of the product lifecycle—design, development, manufacturing, distribution, and post-market support
Ensuring compliance with all applicable quality and regulatory standards and requirements
Providing quality oversight and support for internal/external inspections, regulatory submissions and approvals, CAPA, complaint handling, and change control processes
Represent Device Quality in support of Takeda’s medical device and combination product development initiatives (e.g., new software applications, new IVDs, updates to existing software, bug fixes) throughout clinical development, design transfer, and commercialization
Own DQ deliverables such as risk management documentation, quality plans, traceability matrices, and software validation for IEC 62304 Class A, B, and C SaMD and IVDs
Ensure risk management deliverables (e.g., risk management plan, FMEA, hazard analysis, risk management report) and quality planning activities are completed for assigned projects
Maintain compliance with IEC 62304, IEC 61010, MDR, MDSAP, ISO 13485, ISO 14971, and other relevant global regulations and standards
Provide technical quality support for regulatory filings and design verification/validation activities for SaMD and IVDs
Act as subject matter expert (SME) for assigned programs and products
Lead quality improvement initiatives and design enhancements within lifecycle management of assigned devices and combination products
Conduct quality assessments during supplier qualification for assigned development projects
Support internal and external audits, serving as SME for product lifecycle documentation
Lead and execute commercial lifecycle management activities, including change control, deviation investigations, CAPA, and complaint handling
Qualification
Required
Bachelor's degree in Engineering or equivalent technical discipline, plus at least 5 years of experience in Quality Assurance or Quality Engineering roles for medical devices and/or combination products
Extensive knowledge of international regulations for devices and combination products, including ISO 13485, MDSAP, ISO 14971, MDR, IEC 62304, and 21 CFR Part 820
Experience with commercial development and regulatory filings
Proven ability to work with external manufacturing partners, conduct root cause analysis, and drive effective investigations
Strong operational background with expertise in GDPs, process efficiency, and turnaround time improvement
Experience collaborating with global cross-functional teams; project/program management and operational excellence preferred
Preferred
Advanced degree
Experience in the biotech/device industry; medical device engineering background preferred
Familiarity with digital health solutions
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-08
2026-01-07
Company data provided by crunchbase