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

Takeda is seeking an Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product. The successful candidate 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. Key responsibilities include leading and developing 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, and ensuring line management and key stakeholders are apprised of developments impacting regulatory success.

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)
• 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

Benefits

• Short-term and/or long-term incentives
• Medical, dental, 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