Head of Medical Device & SaMD Quality

Takeda • Lexington, MA

2d

About The Position

OBJECTIVES/PURPOSE Drive the design, implementation, and continuous improvement of operations and quality systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. Lead and develop a global organization, fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence and execute Takeda’s global Quality strategy for medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD) across all business units, geographies, and therapeutic modalities spanning Takeda’s development pipeline and lifecycle management of marketed products. Drive inspection-ready and scalable, compliant, and patient-centric solutions across Takeda’s R&D and commercial portfolio across the entire product lifecycle.

Requirements

• Advanced degree in engineering, life sciences, or related field (B.S. required; M.S./Ph.D. preferred).
• Minimum 10 years of industry experience, including 5 years in medical device and/or combination product quality.
• At least 5+ years of direct leadership and team management experience.
• In-depth knowledge of global medical device and SaMD regulations (FDA, ISO 13485, ISO 14971, MDR/IVDR, MDSAP).
• Proven experience supporting regulatory inspections and driving quality excellence in regulated environments.

Nice To Haves

• Experience working in global matrix organizations and leading cross-cultural teams.
• Familiarity with emerging digital health technologies, agile development practices, and AI/ML-enabled medical devices.
• Experience with both development and commercial-stage product support, including lifecycle management and sustaining engineering.

Responsibilities

• Lead and oversee multiple functional areas including medical devices, combination products, in vitro diagnostics (IVDs), and Software as a Medical Device (SaMD), ensuring compliance with global quality standards.
• Define and lead the global Quality strategy for medical devices, combination products, SaMD, and IVDs across all business units, geographies, and therapeutic modalities—spanning Takeda’s development pipeline and lifecycle management of marketed products.
• Provide senior-level Quality leadership and guidance across design, development, technology transfer, commercialization, and post-market surveillance.
• Ensure global compliance with applicable medical device and software regulations (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP).
• Act as or designate the Device Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC), where applicable.
• Lead and develop a high-performing, globally distributed team, promoting clear accountability, performance management, and talent development.
• Serve as a key Quality thought partner for senior stakeholders across R&D and Commercial to shape Takeda’s strategy in the combination product and digital health space.
• Influence global policy development by participating in relevant industry forums and external regulatory dialogues.
• Collaborate with Regulatory, Engineering, CMC, Safety, Commercial Quality, and Digital teams to support patient-centric innovation.
• Champion quality system initiatives and inspection readiness efforts, including preparation and leadership during internal and external audits.
• Establish and monitor performance indicators to ensure continuous improvement in device and software product quality.
• Build strategies to support efficiencies and innovative solutions.

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: Executive
• Number of Employees: 5,001-10,000 employees