Head Global Quality Device Compliance US/ROW region

Role Summary

Head Global Quality Device Compliance for the US/ROW region responsible for providing strategic direction and oversight for GxP medical devices, including stand-alone devices, combination devices, and Software as a Medical Device (SaMD). Ensures Quality System requirements are established, effective, and maintained in compliance with applicable regulatory requirements. Partners with regional Device Compliance leads and cross-functional stakeholders to uphold global device quality standards and enable safe innovation across the product lifecycle.

Responsibilities

• Provide strategic quality compliance direction and oversight for GxP medical devices for the US and Rest Of World region (excluding EU, CAN, China, and Asia region).
• Serve as main quality compliance lead for Device and Combination Products to ensure Quality System requirements are established, effective, and maintained per US and ROW regulatory requirements.
• Oversee compliant lifecycle management of GxP devices from R&D to discontinuation and establish a framework for Software as a Medical Device to enable safe innovation and patient safety.
• Partner with Device Compliance heads for EU/CAN and China/Asia regions on global device activities and support global compliance strategies in alignment with 1-QMS.
• Support and execute QMS processes supporting Device QMR responsibilities, including oversight of device-related SOPs, quality councils, inspection support, and industry interactions.
• Collaborate with Regulatory Affairs, Device Quality, and PharmSci to ensure aligned quality compliance strategies.
• Serve as Device Management Representative for US and ROW as needed and participate in teams developing global policies and procedures for Device and Combination Products.
• Oversee internal and external audits and inspections, including interactions with Notified Bodies and regulatory investigators, and track and close corrective actions.
• Attend Management Review and Quality Council for Device and Combination Products Quality Systems, assessing quality performance for control, capability, and compliance.
• Engage with stakeholders to sustain Device Quality support for manufacture, packaging, testing, and release, ensuring GMPs, Takeda Quality Standards, and regulatory requirements are met.

Qualifications

• Bachelor‚Äôs degree in a scientific or technical discipline (advanced degree preferred).
• 7‚Äì10 years of experience in medical devices and/or combination products within a regulated healthcare environment, including 5‚Äì7 years in Quality Assurance or Compliance.
• Demonstrated leadership experience (minimum 5 years) with the ability to mentor and coach teams.
• Expert knowledge of US and ROW regulatory requirements for Device and Combination Products.
• Experience with Class I, II, and III sterile and non-sterile medical devices and related regulatory filings.
• Strong analytical and risk-based decision-making skills to address complex compliance challenges.
• Proven collaboration across global, cross-functional teams and regulatory authorities.
• Proactive, innovative mindset focused on continuous improvement and patient safety.

Skills

• GxP compliance for medical devices
• Quality Management Systems (QMS)
• Regulatory affairs coordination (US and ROW)
• Audits and inspections management
• Stakeholder management and cross-functional collaboration
• Risk assessment and decision-making

Education

• Bachelor‚Äôs degree in a scientific or technical discipline (advanced degree preferred).