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Job Description

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

As Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product, you will provide strategic leadership and development to global regulatory subject matter experts to ensure innovative and robust regulatory strategies for medical devices and drug-device combination products, maximizing global regulatory success and minimizing time to approval/clearance.

Establish best practices and builds a strong regulatory community across Global Regulatory Affairs spanning device, combination product, quality, clinical, development and manufacturing interfaces.

Serve as an influential leader internally and externally, shaping regulatory policy and cross-functional decision-making for devices and combination products across major regions (e.g., US, EU, UK, Japan,  China).

How you will contribute:

• Leads and develops a team of regulatory leaders and subject matter experts, overseeing global regulatory strategy and major submissions for an assigned portfolio of medical devices and drug-device combination products, ensuring clear strategy, high-quality execution, and timely approvals/clearances.

• Partners with cross-functional leaders (Regulatory, Development, Clinical, Quality, Safety, Manufacturing, Supply Chain, Market Access, and Medical) to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements for devices and combination products.

• Ensures line management and key stakeholders are apprised of developments impacting regulatory success (e.g., design changes, nonconformances, clinical evidence, labeling/UDI, post-market signals). Anticipates risks and drives mitigation plans consistent with ISO 14971, design controls, and applicable global regulations.

• Represents Global Regulatory Affairs in senior-level governance and in interactions with global regulators and notified bodies, including FDA (CDRH/CDER and Office of Combination Products), EMA/Competent Authorities under EU MDR, MHRA, PMDA, and other agencies as applicable.

• Accountable for ensuring global submissions and lifecycle compliance for devices and combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking under MDR, technical documentation, variations/changes, vigilance). Partners with regional leads, quality, and vendors to ensure compliant, inspection-ready processes and documentation.

• Leads departmental and cross-functional initiatives to improve regulatory strategy, operational excellence, and quality systems interfaces (e.g., design controls, labeling governance, supplier controls, post-market surveillance, digital/connected device considerations). Influences without authority across R&D and Global Regulatory Affairs.

• Provides regulatory strategy leadership for business development and due diligence activities, including assessment of device/combination product classification, regulatory pathways, technical evidence requirements, and lifecycle obligations.

• Monitors and anticipates global regulatory trends impacting devices and combination products (e.g., MDR implementation, FDA guidance, standards such as ISO 13485/14971/IEC 62304, cybersecurity expectations), translating insights into proactive regulatory and evidence strategies.

• Responsible for demonstrating Takeda leadership behaviors.

Minimum Requirements/Qualifications: 

• Advanced degree in a scientific, or engineering discipline (e.g., MS, PhD, PharmD)

• 20+ years of industry experience with 10+ years in Regulatory Affairs and demonstrated leadership in medical devices and/or drug-device combination products.

• Significant experience leading, reviewing, authoring, or managing regulatory submissions for devices and/or combination products (e.g., IDE, 510(k), De Novo, PMA, CE marking/MDR technical docu