Vice President, Quality Assurance & Regulatory Affairs

Overview

This role will be on a hybrid schedule at one of the following offices : El Segundo, CA / Goleta, CA / Auburn, MA / Charlton, MA / Franklin, MA

Why this role matters

Shape the future of quality and regulatory excellence at a global MedTech innovator

At KARL STORZ, innovation and precision have defined who we are for more than 80 years. As a privately held, family-owned leader in minimally invasive surgery and operating room integration, we serve healthcare providers worldwide with technologies that improve outcomes and transform patient care. With over 9,500 associates globally, including 2,600 across North America. We are proud to set the standard in craftsmanship, innovation, and customer partnership.

Now, we\'re looking for a visionary Vice President of Quality & Regulatory Affairs (North America) to elevate our quality systems, safeguard patient safety, and lead regulatory strategy for one of the most respected names in MedTech. This is a rare opportunity to drive impact across our full value chain, working alongside departments across 6 sites - from R&D through commercialization and post-market - while partnering closely with executive leadership to shape the future of healthcare technology.

The Vice President of Quality & Regulatory Affairs, North America, will oversee the Quality and Regulatory Affairs functions in the North America region and will look to harmonize the North America quality management systems and regulatory processes with the global Quality Management and Patient Health & Regulatory Compliance functions.

What you\'ll do

As the regional head of Quality & Regulatory Affairs, you will :

• Set strategic direction for quality and regulatory operations across North America, harmonizing with global standards.
• Lead with influence - partnering with R&D, Operations, Commercial, and Global teams to ensure quality and compliance at every stage of the product lifecycle.
• Engage with regulators - oversee submissions, inspections, and audits with the FDA and other authorities, ensuring flawless execution.
• Champion continuous improvement , advance risk management, CAPA, and quality system maturity across our manufacturing and distribution sites.
• Inspire leadership - mentor and grow teams, fostering a culture of collaboration, accountability, and operational excellence.

What you bring

Why join KARL STORZ

Who we are

Ready to lead with impact? Join us in setting the standard for quality and compliance in MedTech. Apply today and help us continue to change lives, together.

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