Americas Quality Assurance and Regulatory Director
About the role
Trelleborg Medical Solutions is seeking a Quality Assurance and Regulatory Director - Americas, based from their Minneapolis MN headquarters. This position offers competitive compensation, generous benefits, and the opportunity to work in a clean, climate-controlled environment.
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.
Requirements
Bachelor’s degree in engineering, Life Science, or related technical field; Master’s preferred.
10+ years of progressive experience in Quality Assurance and/or Regulatory Affairs; 5 years within the medical device industry.
Demonstrated leadership experience in a global, matrixed organization.
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.
Qualifications
Regional to the Americas (North, South and Central).
Must be accessible to a major airport.
Travel expected up to 50%.
Skills
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.
Benefits
Competitive compensation: $160-180,000 DOE + bonus opportunities!
Generous benefits package: Includes health, dental, vision, STD, LTD, life, 401k, paid time off, tuition reimbursement, and more!
Clean work environment: Enjoy working in a very clean and climate-controlled environment every day!
Greater opportunity for impact: You will have the autonomy and support to lead the production team and impact the production of life-saving devices.
Growth and advancement: Join a global company that loves to promote from within and allows for advancement into one of their many other U.S. locations!
Pay
$160-180,000 DOE + bonus opportunities!
Schedule
Not specified
Geography and Travel Requirements
Regional to the Americas (North, South and Central).
Must be accessible to a major airport.
Travel expected up to 50%.