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

Takeda•Boston, MA

2d•$238,000 - $374,000•Hybrid

About The Position

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.

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.
Must work well with others and within global teams.
Able to bring working teams together for common objectives.
Acceptable and independent skills 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 creative solutions and strategies, including risk mitigation strategies.

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.
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.