Executive Director Global Regulatory Affairs CMC - Device and Combination Products
Takeda
2 months ago
Remote friendly (Cambridge, MA)
United States
Corporate Functions
How you will contribute:
- Lead and develop a team of regulatory leaders and subject matter experts; oversee global regulatory strategy and major submissions for a 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, Medical) to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements.
- Keep line management and stakeholders apprised of developments impacting regulatory success (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 governance and interactions with global regulators and notified bodies (e.g., FDA CDRH/CDER/OCP; EMA/Competent Authorities under EU MDR; MHRA; PMDA).
- Ensure global submissions and lifecycle compliance for devices/combination products (IDE, 510(k), De Novo, PMA, CE marking under MDR, technical documentation, variations/changes, vigilance) with inspection-ready processes.
- Lead initiatives to improve regulatory strategy, operational excellence, and quality systems interfaces (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 (classification, pathways, technical evidence requirements, lifecycle obligations).
- Monitor and translate global regulatory trends (MDR implementation, FDA guidance, ISO 13485/14971/IEC 62304, cybersecurity expectations) into proactive regulatory and evidence strategies.
- Demonstrate leadership behaviors.
Minimum Requirements/Qualifications:
- Advanced degree in a scientific or engineering discipline (e.g., MS, PhD, PharmD).
- 20+ years industry experience, with 10+ years in Regulatory Affairs; leadership experience in medical devices and/or drug-device combination products.
- Significant experience leading/reviewing/authoring/managing regulatory submissions for devices/combination products (IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation), including major deficiency responses and negotiation of requirements.
- Strong knowledge of device/combination product development and regulatory requirements, including FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance (other regions a plus).
- Ability to interpret complex technical, nonclinical, clinical, and manufacturing issues across programs.
- Expert guidance in global regulatory strategy (technical documentation/Design History File, design controls, human factors/usability, biocompatibility, software/cybersecurity as applicable, post-market lifecycle planning).
- Strong oral and written communication; timeline management and negotiation; integrity and adaptability.
- Ability to work effectively with others in global teams and bring teams together for common objectives.
- Lead and develop a team of regulatory leaders and subject matter experts; oversee global regulatory strategy and major submissions for a 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, Medical) to align evidence generation, usability/human factors, risk management, and value messaging to regulatory and access requirements.
- Keep line management and stakeholders apprised of developments impacting regulatory success (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 governance and interactions with global regulators and notified bodies (e.g., FDA CDRH/CDER/OCP; EMA/Competent Authorities under EU MDR; MHRA; PMDA).
- Ensure global submissions and lifecycle compliance for devices/combination products (IDE, 510(k), De Novo, PMA, CE marking under MDR, technical documentation, variations/changes, vigilance) with inspection-ready processes.
- Lead initiatives to improve regulatory strategy, operational excellence, and quality systems interfaces (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 (classification, pathways, technical evidence requirements, lifecycle obligations).
- Monitor and translate global regulatory trends (MDR implementation, FDA guidance, ISO 13485/14971/IEC 62304, cybersecurity expectations) into proactive regulatory and evidence strategies.
- Demonstrate leadership behaviors.
Minimum Requirements/Qualifications:
- Advanced degree in a scientific or engineering discipline (e.g., MS, PhD, PharmD).
- 20+ years industry experience, with 10+ years in Regulatory Affairs; leadership experience in medical devices and/or drug-device combination products.
- Significant experience leading/reviewing/authoring/managing regulatory submissions for devices/combination products (IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation), including major deficiency responses and negotiation of requirements.
- Strong knowledge of device/combination product development and regulatory requirements, including FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance (other regions a plus).
- Ability to interpret complex technical, nonclinical, clinical, and manufacturing issues across programs.
- Expert guidance in global regulatory strategy (technical documentation/Design History File, design controls, human factors/usability, biocompatibility, software/cybersecurity as applicable, post-market lifecycle planning).
- Strong oral and written communication; timeline management and negotiation; integrity and adaptability.
- Ability to work effectively with others in global teams and bring teams together for common objectives.