Head of Medical Device & SaMD Quality

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• 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. 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.

• Leadership & People – Direct reports: 7–10;
  Indirect reports: 25–30
• Geographic Scope – Global

• 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.
• 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.

• Demonstrated knowledge of global regulations and guidelines 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’s 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.