Vice President of Regulatory Affairs and Quality

VP, Regulatory Affairs & Quality — Class III Med Tech Leadership

Join a fast‑growing med‑tech innovator that has successfully achieved PMA approval and FDA clearance for its Class III platform — and is now scaling globally. We’re hiring a Vice President of Regulatory Affairs & Quality to lead the next chapter of regulatory strategy, quality excellence, and worldwide expansion.

Reporting directly to the CEO, this executive will serve as the company’s top authority on regulatory and quality matters, shaping strategy, guiding high‑stakes decisions, and ensuring the organization maintains a world‑class compliance posture as it accelerates commercialization.

• Executive regulatory leadership — Advise the CEO and Board, influence corporate strategy, and drive mission‑critical milestones post‑approval.
• Global regulatory strategy — Build and execute global pathways (EU MDR, Health Canada, PMDA, NMPA, etc.) to expand beyond initial FDA success.
• Quality & compliance ownership — Lead the integrated RA/QA function, QMS effectiveness, inspection readiness, CAPA, complaints, and post‑market surveillance.
• Cross‑functional alignment — Partner with R&D, Clinical, Manufacturing, and Commercial to embed regulatory and quality requirements into product and business strategy.
• Risk leadership — Serve as the final internal authority on regulatory and quality risk, ensuring clear, data‑driven decision support.
• Organizational scale — Build and grow a high‑performing RA/QA organization to support global commercialization.

• 15–20+ years in Regulatory Affairs for medical devices
  , with deep Class III expertise
• Proven success leading IDE, PMA, and FDA interactions
• Experience owning RA/QA in a startup or scaling environment
• Strong executive judgment, risk communication, and cross‑functional leadership
• Bachelor’s degree required; advanced degree and RAC certification preferred

With PMA and FDA approval already secured, the company is entering a pivotal growth phase. Your leadership will define how the organization scales globally, maintains compliance excellence, and expands its Class III portfolio.