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

Americas Quality Assurance and Regulatory Director