Head of Medical Device & Software as Medical Device (SaMD)

Role Summary

Head of Medical Device & Software as a Medical Device (SaMD)

Responsibilities

• Set and execute Takeda‚Äôs 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‚Äôs development pipeline and lifecycle management of marketed products. Drive inspection-ready and escalable, compliant, and patient-centric solutions across Takeda‚Äôs R&D and commercial portfolio.
• 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 across the entire product lifecycle.

Qualifications

• Minimum 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.
• Preferred requirements
  • 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.

Skills

• Demonstrated knowledge of global regulations and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP, and global quality systems.
• Strong background in software development life cycle, SaMD/SiMD validation, and quality oversight.
• Ability to translate and articulate appropriate strategies and activities to ensure compliance to cGMP regulations and expectations.
• A comprehensive understanding of pharmaceutical development, manufacturing, testing, and related technologies.
• Demonstrated ability to lead and develop global teams, establish strategic priorities, and drive execution.
• Proven track record of working with executive leadership and influencing decision-making across cross-functional stakeholders.
• Highly effective communicator who establishes a compelling vision and encourages open dialogue across diverse viewpoints.
• Holds employees accountable to deliver on expectations while embodying Takeda‚Äôs values and priorities.
• Promotes growth through development opportunities, mentoring, and support for career advancement.
• Acts as a role model for taking smart, compliant risks that advance innovation.

Education

• Minimum requirements: Advanced degree in engineering, life sciences, or related field; B.S. required; M.S./Ph.D. preferred.