Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product
Takeda
August 08, 2026
Remote friendly (Boston, MA)
United States
$238,000 - $374,000 USD yearly
Corporate Functions
Executive Director, Global Regulatory Affairs – CMC Devices and Drug-Device Combination Products
How you will contribute:
- Lead and develop a team of regulatory leaders; own global regulatory strategy and major device/combination product submissions to deliver timely approvals/clearances.
- Partner cross-functionally (Regulatory, Development, Clinical, Quality, Safety, Manufacturing, Supply Chain, Market Access, Medical) to align evidence generation, usability/human factors, risk management, and value messaging.
- Anticipate regulatory risks (design changes, nonconformances, clinical evidence, labeling/UDI, post-market signals) and drive mitigation consistent with ISO 14971 and design controls.
- Represent Regulatory Affairs with senior governance and global regulators/notified bodies (e.g., FDA, EMA/EU MDR, MHRA, PMDA).
- Ensure global submissions and lifecycle compliance (IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation, variations/changes, vigilance).
- Drive initiatives to improve regulatory strategy and quality-system interfaces (design controls, labeling governance, supplier controls, post-market surveillance, digital/connected devices).
- Provide regulatory strategy for business development/due diligence and assess classification, pathways, evidence needs, and lifecycle obligations.
Minimum requirements/qualifications:
- Advanced degree (MS/PhD/PharmD) in scientific/engineering discipline.
- 20+ years industry experience; 10+ years Regulatory Affairs leadership in medical devices and/or drug-device combination products.
- Deep experience authoring/managing device/combination submissions (IDE/510(k)/De Novo/PMA/CE/MDR), including deficiency responses and requirement negotiation.
- Working knowledge of FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance; other regions preferred.
- Expertise across technical, nonclinical/clinical, and manufacturing issues; strong communication and negotiation; global teamwork.
Benefits (explicit): medical/dental/vision insurance, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.
How you will contribute:
- Lead and develop a team of regulatory leaders; own global regulatory strategy and major device/combination product submissions to deliver timely approvals/clearances.
- Partner cross-functionally (Regulatory, Development, Clinical, Quality, Safety, Manufacturing, Supply Chain, Market Access, Medical) to align evidence generation, usability/human factors, risk management, and value messaging.
- Anticipate regulatory risks (design changes, nonconformances, clinical evidence, labeling/UDI, post-market signals) and drive mitigation consistent with ISO 14971 and design controls.
- Represent Regulatory Affairs with senior governance and global regulators/notified bodies (e.g., FDA, EMA/EU MDR, MHRA, PMDA).
- Ensure global submissions and lifecycle compliance (IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation, variations/changes, vigilance).
- Drive initiatives to improve regulatory strategy and quality-system interfaces (design controls, labeling governance, supplier controls, post-market surveillance, digital/connected devices).
- Provide regulatory strategy for business development/due diligence and assess classification, pathways, evidence needs, and lifecycle obligations.
Minimum requirements/qualifications:
- Advanced degree (MS/PhD/PharmD) in scientific/engineering discipline.
- 20+ years industry experience; 10+ years Regulatory Affairs leadership in medical devices and/or drug-device combination products.
- Deep experience authoring/managing device/combination submissions (IDE/510(k)/De Novo/PMA/CE/MDR), including deficiency responses and requirement negotiation.
- Working knowledge of FDA (CDRH/CDER/OCP), EU MDR/IVDR, and post-market/vigilance; other regions preferred.
- Expertise across technical, nonclinical/clinical, and manufacturing issues; strong communication and negotiation; global teamwork.
Benefits (explicit): medical/dental/vision insurance, 401(k) with match, disability, life insurance, tuition reimbursement, paid volunteer time off, holidays, well-being benefits; up to 80 hours sick time/year; up to 120 hours paid vacation for new hires.