Executive Director, Global Regulatory Affairs CMC Devices and Drug-Device Combination Product
Takeda
August 30, 2026
Remote friendly (Boston, MA)
United States
$238,000 - $374,000 USD yearly
Corporate Functions
Responsibilities:
- Lead and develop regulatory leaders/expert team; oversee global regulatory strategy and major submissions for medical devices and drug-device combination products to ensure timely, high-quality approvals/clearances.
- Partner cross-functionally to align evidence generation, usability/human factors, risk management, and value messaging with regulatory/access requirements.
- Manage stakeholders on developments affecting regulatory success; anticipate and mitigate risks consistent with ISO 14971, design controls, and global regulations.
- Represent Global Regulatory Affairs with regulators and notified bodies (e.g., FDA, EMA/competent authorities, MHRA, PMDA).
- Ensure global submissions and lifecycle compliance (IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation, variations/changes, vigilance); support inspection-ready processes and documentation.
- Lead initiatives to improve regulatory strategy, operational excellence, and quality system interfaces (design controls, labeling governance, supplier controls, post-market surveillance, digital/connected device considerations).
- Provide regulatory strategy for business development/due diligence (classification, regulatory pathways, evidence requirements, lifecycle obligations).
- Monitor global regulatory trends and translate into proactive regulatory/evidence strategy.
Minimum Requirements:
- Advanced degree (scientific/engineering; e.g., MS/PhD/PharmD).
- 20+ years industry experience, including 10+ years in Regulatory Affairs with demonstrated leadership in medical devices and/or drug-device combination products.
- Extensive experience leading/reviewing/authoring/managing device/combination product regulatory submissions (IDE, 510(k), De Novo, PMA, CE marking/MDR) including major deficiency responses and requirement negotiation.
- Strong knowledge of device/combination product development and regulations (FDA, EU MDR/IVDR) and post-market/vigilance; other regions preferred.
- Ability to interpret complex technical/clinical/manufacturing issues and provide expert guidance on regulatory strategy, design controls, human factors/usability, biocompatibility, software/cybersecurity (as applicable), and post-market planning.
- Strong communication, timeline management, negotiation, integrity, and adaptability; ability to lead global teams.
Benefits (U.S. employees, may include):
- Short- and/or long-term incentives; medical/dental/vision insurance; 401(k) with company match; disability coverage; basic 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.
- Lead and develop regulatory leaders/expert team; oversee global regulatory strategy and major submissions for medical devices and drug-device combination products to ensure timely, high-quality approvals/clearances.
- Partner cross-functionally to align evidence generation, usability/human factors, risk management, and value messaging with regulatory/access requirements.
- Manage stakeholders on developments affecting regulatory success; anticipate and mitigate risks consistent with ISO 14971, design controls, and global regulations.
- Represent Global Regulatory Affairs with regulators and notified bodies (e.g., FDA, EMA/competent authorities, MHRA, PMDA).
- Ensure global submissions and lifecycle compliance (IDE, 510(k), De Novo, PMA, CE marking/MDR technical documentation, variations/changes, vigilance); support inspection-ready processes and documentation.
- Lead initiatives to improve regulatory strategy, operational excellence, and quality system interfaces (design controls, labeling governance, supplier controls, post-market surveillance, digital/connected device considerations).
- Provide regulatory strategy for business development/due diligence (classification, regulatory pathways, evidence requirements, lifecycle obligations).
- Monitor global regulatory trends and translate into proactive regulatory/evidence strategy.
Minimum Requirements:
- Advanced degree (scientific/engineering; e.g., MS/PhD/PharmD).
- 20+ years industry experience, including 10+ years in Regulatory Affairs with demonstrated leadership in medical devices and/or drug-device combination products.
- Extensive experience leading/reviewing/authoring/managing device/combination product regulatory submissions (IDE, 510(k), De Novo, PMA, CE marking/MDR) including major deficiency responses and requirement negotiation.
- Strong knowledge of device/combination product development and regulations (FDA, EU MDR/IVDR) and post-market/vigilance; other regions preferred.
- Ability to interpret complex technical/clinical/manufacturing issues and provide expert guidance on regulatory strategy, design controls, human factors/usability, biocompatibility, software/cybersecurity (as applicable), and post-market planning.
- Strong communication, timeline management, negotiation, integrity, and adaptability; ability to lead global teams.
Benefits (U.S. employees, may include):
- Short- and/or long-term incentives; medical/dental/vision insurance; 401(k) with company match; disability coverage; basic 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.