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SaMD and IVD Principal Manager

Lexington, Massachusetts
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0170886 Date posted 01/06/2026 Location Lexington, Massachusetts

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Job Description

OBJECTIVES / PURPOSE

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.

ACCOUNTABILITIES

  • 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.

DIMENSIONS AND ASPECTS

Technical / Functional Expertise

  • Strong scientific and technical expertise to analyze complex product data and make sound, risk-based quality decisions.

  • Ensure compliance of commercial and clinical devices and combination products for global markets, including timely completion of vigilance assessments, investigations, incident escalation, and CAPA activities.

Leadership

  • Demonstrated ability to build authentic relationships, foster trust, and collaborate effectively as a team leader or member.

  • Skilled in constructive challenge, clear communication, and delivering results through teamwork.

Decision-Making and Autonomy

  • Strong decision-making skills, even under uncertainty.

  • Drive continuous improvement to proactively mitigate risks and maintain effective operations aligned with business needs.

Interaction

  • Work productively within cross-functional teams and build strong relationships with Device Quality partners and global business process owners.

Innovation

  • Analyze product information to identify and implement process improvements.

Complexity

  • Navigate ambiguity while making quality decisions, assessing performance, and driving change.

EDUCATION, COMPETENCIES, AND SKILLS

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.

Desired:

  • Advanced degree.

  • Experience in the biotech/device industry; medical device engineering background preferred.

  • Familiarity with digital health solutions.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$111,800.00 - $175,670.00


The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. 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. 

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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