Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product

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.

Responsibilities

• 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.
• Promotes alignment between 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.
• Serves 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).

Requirements

• 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 documentation), including major deficiency responses and negotiation of requirements.
• Strong working knowledge of device and combination product development and regulatory requirements, including FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance obligations; experience with other regions a plus.
• Understands and interprets complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to device/combination regulatory requirements and strategy.
• Provides expert guidance on global device/combination regulatory strategy, including technical documentation/Design History File expectations, design controls, human factors/usability, biocompatibility, software and cybersecurity considerations (as applicable), and post-market lifecycle planning.
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers innovative solutions and strategies, including risk mitigation strategies.

Qualifications

• Must work well with others and within global teams. Able to bring working teams together for common objectives.

Skills

• Expertise in medical devices and drug-device combination products regulatory requirements.
• Strong leadership and strategic thinking skills.
• Excellent communication and negotiation skills.
• Ability to anticipate and mitigate regulatory risks.

Benefits

Takeda offers a competitive compensation and benefits package, including:

• U.S. Base Salary Range: $238,000.00 - $374,000.00
• Short-term and long-term incentives
• Medical, dental, and vision insurance
• 401(k) plan and company match
• Short-term and long-term disability coverage
• Basic life insurance
• Tuition reimbursement program
• Paid volunteer time off
• Company holidays
• Well-being benefits

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible to receive up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

Pay

U.S. based employees may be eligible for a salary range of $238,000.00 - $374,000.00.

Schedule

This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy.