Director, Regulatory Affairs – Americas & Anz

IR Jobs

Remote
Base: 154,000.00 - 230,000.00 usd annual; bonus/eq...
Medical device regulations us
Regulatory strategy leadership
Product and facility licensing
Set and lead the regulatory strategy for the Americas (US, Ca & Latin America) & ANZ regions, enabling commercial growth & innovation, geographic expansion, and manufacturing/supply‑chain transformations while ensuring rigorous compliance with global and regional regulations

Job Summary

  • Set and lead the regulatory strategy for the Americas (US, Ca & Latin America) & ANZ regions, enabling commercial growth & innovation, geographic expansion, and manufacturing/supply‑chain transformations while ensuring rigorous compliance with global and regional regulations.
  • Serve as the senior RA business partner to executive leadership, drive proactive regulatory planning, and ensure that regulatory realities are embedded in business strategy across Revenue, Marketing, Operations, Supply‑Chain in close collaboration with Quality, legal and other regional & global RA leaders.
  • Build, mentor and develop the Americas + ANZ RA organization: talent development, performance management, succession planning, ensure adequate skills and capacity to meet strategic demands.

Matching Summary

Set and lead the regulatory strategy for the Americas (US, Ca & Latin America) & ANZ regions, enabling commercial growth & innovation, geographic expansion, and manufacturing/supply‑chain transformations while ensuring rigorous compliance with global and regional regulations.

Salary

Base: 154,000.00 - 230,000.00 USD Annual; Bonus/Equity: Not specified; Benefits: comprehensive medical, vision, dental, and life, AD&D, short-term and long-term disability insurance, sleep care management, Health Savings Account (HSA), Flexible Spending Account (FSA), commuter benefits, 401(k), Employee Stock Purchase Plan (ESPP), Employee Assistance Program (EAP), and tuition assistance, Flexible Time Off (FTO), 11 paid holidays plus 3 floating days and 14 weeks of primary caregiver or two weeks of secondary caregiver leave

Skills & Requirements

Must-have

  • Medical device regulations US
  • Regulatory strategy leadership
  • Product and facility licensing
  • Liaison with regulatory authorities
  • Global to regional alignment

Nice-to-have

  • Strategic business partner
  • Proactive regulatory planning
  • Talent development and mentorship
  • Executive presence and credibility
  • Change management and resilience

Key Requirements

  • Minimum 10 years regulatory affairs experience
  • 3-5 years leadership role
  • Bachelor's or Master's degree
  • Advanced/regulatory certification desirable
  • Fluent in English, Spanish/Portuguese preferred

Work Rights

Not specified

Tailored Resume

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