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

Role Summary

Head of Medical Device & Software as a Medical Device (SaMD) at Takeda. Responsible for defining and leading global Quality strategy and systems for medical devices, combination products, IVDs, and SaMD across all units and geographies; building and directing a high-performing, global organization to ensure regulatory readiness, patient safety, and continuous quality improvement throughout the product lifecycle.

Responsibilities

• Lead and oversee multiple functional areas including medical devices, combination products, IVDs, and 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‚Äîspanning development pipelines and lifecycle management of marketed products.
• Provide senior-level Quality leadership 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 PRRC where applicable.
• Lead and develop a high-performing, globally distributed team, promoting accountability, performance management, and talent development.
• Serve as a key Quality thought partner for senior stakeholders to shape strategy in the combination product and digital health space.
• Influence global policy development by participating in industry forums and 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, 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.

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

• Global regulatory knowledge for medical devices and SaMD
• Software development lifecycle and SaMD/SiMD validation
• cGMP compliance and risk-based decision making
• Strategic leadership and cross-functional collaboration
• Executive communication and stakeholder management
• Quality system implementation and audit readiness

Education

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