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

Job Description 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 build 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 Lead and develop 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. Partner 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. Ensure line management and key stakeholders are apprised of developments impacting regulatory success (e.g., design changes, nonconformances, clinical evidence, labeling/UDI, post‑market signals). Anticipate risks and drive mitigation plans consistent with ISO 14971, design controls, and applicable global regulations. Represent 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). Partner with regional leads, quality, and vendors to ensure compliant, inspection‑ready processes and documentation. Lead 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). Influence without authority across R&D and Global Regulatory Affairs. Provide 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. Monitor and anticipate 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. Demonstrate 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 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. Understand and interpret complex technical, nonclinical, clinical, and manufacturing issues across multiple programs as they relate to device/combination regulatory requirements and strategy. Provide 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. Demonstrate 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 identify regulatory issues; offer innovative solutions and strategies, including risk mitigation strategies. Work well with others and within global teams. More About Us At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best‑in‑class patient support programs. Takeda is a patient‑focused company that will inspire and empower you to grow through life‑changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. This position is currently classified as "hybrid" following Takeda's Hybrid and Remote Work policy. Takeda Compensation and Benefits Summary For Location: Boston, MA U.S. Base Salary Range: $238,000.00 - $374,000.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. 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 for short‑term and/or long‑term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short‑term and long‑term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 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 Boston, MA Worker Type Employee Worker Sub‑Type Regular Time Type Full time Job Exempt Yes. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr Initial Therapeutics, Inc.