SaMD and IVD Principal Manager

Takeda • Lexington, MA

20h

About The Position

The SaMD and IVD Principal Manager is an experienced quality and technical professional responsible for: 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.

Requirements

• 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.

Nice To Haves

• Advanced degree.
• Experience in the biotech/device industry; medical device engineering background preferred.
• Familiarity with digital health solutions.

Responsibilities

• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees