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
Job Summary
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.
Serve as an influential leader internally and externally, shaping regulatory policy and cross-functional decision-making for devices and combination products across major regions.
Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
Matching Summary
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.
Salary
Base: $238,000.00 - $374,000.00; Bonus/Equity: Not specified; Benefits: Medical, dental, vision, 401(k), disability, life insurance, tuition reimbursement, PTO
Skills & Requirements
Must-have
global regulatory strategy
drug-device combination products
medical device regulatory affairs
regulatory submissions
regulatory policy shaping
Nice-to-have
influential leadership
cross-functional decision-making
patient-focused company
foster inclusive workplace
Key Requirements
20+ years industry experience
10+ years Regulatory Affairs
Advanced degree in science/engineering
Experience with FDA, EU MDR/IVDR
Experience with device/combination product submissions