Americas Quality Assurance and Regulatory Director

Americas Quality Assurance and Regulatory Director

Imagine leveraging your expertise while working for one of the leading contract manufacturers in the world. Seize this rare opportunity to be part of a healthcare and medical business unit with the support and stability of an organization that has been in business for over 100 years.

Trelleborg Medical Solutions is seeking a Quality Assurance and Regulatory Director - Americas, based from their Minneapolis MN headquarters. As a valued team member with Trelleborg, you will enjoy:

• 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!

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.
• 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.

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%

Trelleborg Medical Solutions partners with the world's leading medical device and biopharmaceutical companies, collaborating from concept to commercialization to bring to market impactful solutions that improve patient quality of life. It leverages decades of design and manufacturing experience, in-depth knowledge of polymer materials and a deep understanding of customer applications and end-use environments to deliver pioneering, engineered solutions for transformative health technologies. Utilizing its global quality system and engineering and manufacturing network, the company is a production partner of choice for medical devices and biopharmaceutical companies.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.