Executive Director, Global Regulatory Affairs Cmc Devices And Drug-device Combination Product

Takeda

Boston, MA, US
Base: $238,000.00 - $374,000.00; bonus/equity: sho...
Hybrid
10+ years regulatory affairs experience
Medical device submission management
Drug-device combination product strategy
This role provides strategic leadership to global regulatory subject matter experts to ensure innovative strategies for medical devices and drug-device combination products

Job Summary

  • This role provides strategic leadership to global regulatory subject matter experts to ensure innovative strategies for medical devices and drug-device combination products.
  • The successful candidate will represent Global Regulatory Affairs in senior-level governance and interactions with major agencies including the FDA, EMA, MHRA, and PMDA.
  • Takeda offers a competitive salary range of $238,000.00 - $374,000.00 along with comprehensive benefits including medical insurance, 401(k) matching, and up to 120 hours of paid vacation.

Matching Summary

This role provides strategic leadership to global regulatory subject matter experts to ensure innovative strategies for medical devices and drug-device combination products.

Salary

Base: $238,000.00 - $374,000.00; Bonus/Equity: Short-term and long-term incentives eligible; Benefits: Medical, dental, vision, 401(k) match, disability, life insurance, tuition reimbursement, 120 hours vacation

Skills & Requirements

Must-have

  • 10+ years Regulatory Affairs experience
  • Medical device submission management
  • Drug-device combination product strategy
  • FDA CDER CDRH OCP knowledge
  • EU MDR technical documentation
  • ISO 14971 risk management

Nice-to-have

  • Strong negotiation skills
  • Cross-functional team leadership
  • Cybersecurity regulatory awareness
  • Global stakeholder influence
  • Innovative problem solving

Key Requirements

  • Advanced degree in scientific or engineering discipline
  • 20+ years industry experience
  • 10+ years in Regulatory Affairs
  • Experience with IDE, 510(k), PMA, CE marking
  • Expertise in design controls and human factors

Work Rights

Not specified

Tailored Resume

Cover Letter