Director, Regulatory Affairs – Americas & Anz

ResMed

Base: $154,000.00 - $230,000.00 usd annual; bonus/...
Deep knowledge of fda and health canada regulations
10+ years medical device regulatory experience
3-5 years leadership managing regulatory teams
This role involves setting and leading the regulatory strategy for the Americas and ANZ regions to enable commercial growth and innovation

Job Summary

  • This role involves setting and leading the regulatory strategy for the Americas and ANZ regions to enable commercial growth and innovation.
  • The successful candidate will serve as a senior business partner to executive leadership while driving proactive regulatory planning and ensuring rigorous compliance.
  • ResMed offers a comprehensive benefits package including flexible time off, health insurance, 401(k), and tuition assistance to support employee growth.

Matching Summary

This role involves setting and leading the regulatory strategy for the Americas and ANZ regions to enable commercial growth and innovation.

Salary

Base: $154,000.00 - $230,000.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive medical, vision, dental, life, 401(k), ESPP, FTO

Skills & Requirements

Must-have

  • Deep knowledge of FDA and Health Canada regulations
  • 10+ years medical device regulatory experience
  • 3-5 years leadership managing regulatory teams
  • Experience with US, Canada, LATAM, and ANZ markets
  • Strategic planning for product and facility licensing

Nice-to-have

  • Fluency in Spanish or Portuguese for LATAM coverage
  • RAC certification in Regulatory Affairs
  • Experience with MDSAP and ISO 13485 audits
  • Strong stakeholder management and negotiation skills
  • Willingness to travel across the Americas region

Key Requirements

  • Bachelor's or Master's degree in Life Sciences or related field
  • Minimum 10 years of regulatory affairs experience in medical devices
  • At least 3-5 years in a leadership role
  • Advanced regulatory certification (e.g., RAC) highly desirable
  • Demonstrated ability to navigate multi-jurisdictional regulatory environments

Work Rights

Not specified

Tailored Resume

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