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

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Job Description

OBJECTIVES/PURPOSE

• Set 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 escalable,  compliant, and patient-centric solutions across Takeda’s 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.

SCOPE 

Leadership/People:

No. of direct reports: 7-10
No. of indirect reports: 25-30

Geographic Scope:

Global

ACCOUNTABILITIES

• 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.

DIMENSIONS AND ASPECTS 

Technical/Functional (Line) Expertise

• 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.

Leadership

• 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.

Decision-making and Autonomy

• Makes high-impact decisions with accountability for results and alignment with Takeda’s quality, compliance, and business objectives.
• Applies structured risk-based thinking to address challenges and identify sustainable solutions.
• Makes risk-based decisions on quality issues and product disposition, ensuring patient safety and cGMP compliance.
• Analyzes complex data and applies judgment to make timely decisions, even with limited information.
• Empowers hiring and resource decisions within budget and organizational guidelines.
• Has flexible and creative problem-solving skills.

Interaction

• Work within complex organizations and across functions, at all levels where the incumbent may not have direct authority.
• Builds and maintains strong relationships with internal teams, global stakeholders, external partners, and regulatory bodies.
• Leads with clarity and poise in high-pressure or ambiguous situations.
• Manages long-term strategic efforts while balancing short-term operational demands.
• Collaborates across Takeda’s network and serves as a trusted partner in executive-level interactions.

Innovation

• Drives improvement through innovation, promotes digital thinking, and fosters adoption of next-gen quality capabilities.

• Encourages continuous learning and experimentation within the quality organization.

Complexity

·       Oversees a complex and diverse portfolio of products—including devices, SaMD, IVDs, and combination products—spanning multiple geographies, business units, therapeutic modalities, and evolving global regulatory landscapes.

·       Navigates complex stakeholder environments, competing priorities, and evolving global regulations.

·       Leads enterprise-level quality initiatives that address broad strategic needs.

·       Develops solutions to complex Quality issues which potentially impact patient safety and compliance.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• 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.

#GMSGQ #ZR-1, #LI-MA1

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:

$208,200.00 - $327,140.00

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

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