Americas Quality Assurance and Regulatory Director

Tasks and Responsibilities

• Own and govern the effectiveness of the Americas Quality Management System in compliance with ISO 13485, FDA QSR, and applicable international standards.
• Serve as delegated ISO 13485 Management Representative and report on QMS effectiveness to executive management.
• Define and execute regional regulatory strategy aligned with global business objectives.
• Oversee product/material registrations, listings, certifications, and technical documentation throughout the product lifecycle.
• Lead inspection readiness and act as primary interface with FDA, Notified Bodies, and international regulatory authorities.
• Oversee vigilance, medical device reporting, recalls, and field actions across the Americas.
• Drive operational quality excellence through CAPA, nonconformance management, and continuous improvement initiatives.
• Serve as senior quality interface for key customers, supporting audits and quality agreements.
• Lead, develop, and mentor a regional team of quality and regulatory professionals.
• Ensure training and competency development for quality systems across regional operations.
• Maintain regulatory intelligence and proactively assess impact of regulatory changes.
• Periodically benchmark cost of quality operations with industry peers.

Education and Experience

• Bachelor’s degree in engineering, Life Science, or related technical field; Master’s preferred.
• 15 years of progressive experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Demonstrated leadership experience in a global, matrixed organization.

Competencies

• Expert knowledge of FDA QSR, 21 CFR (801, 803, 806, 807, 820), ISO 13485, ISO 14971, MDR/MDD.
• Strong regulatory intelligence and risk-based decision making skills.
• Ability to manage multiple priorities and lead through influence.
• Excellent written, verbal, and executive communication skills.

Geography and Travel Requirements

• Regional to the Americas (North, South and Central)
• Must be accessible to a major airport
• Travel expected up to 50%