Vice President, Quality Assurance & Regulatory Affairs

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

 

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

 

Why this role matters:

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:

• 15+ years of quality and regulatory affairs experience in the medical device industry, with 10+ years at the senior executive level.
• Bachelor’s degree in life sciences, engineering, or related field (advanced degree preferred).
• Deep knowledge of global regulatory frameworks (FDA QSR, ISO, GMP) and proven track record of leading audits, submissions, and agency interactions.
• Executive presence with the ability to influence in a matrixed, global environment.
• A passion for advancing patient safety through the highest standards of quality.
• Willingness to travel up to 50% (domestic and international).

 

Why join KARL STORZ:

• Impact with purpose: Every product, process, and decision contribute directly to improving lives.
• Legacy of innovation: Be part of a company with 80+ years of pioneering MedTech solutions.
• Global reach, family values: Experience the scale of a worldwide leader, with the stability and long-term vision of a family-owned enterprise.
• Leadership visibility: Report directly to the North America President, with dotted-line connection to the Global Head of Quality & Regulatory Affairs.
• Career-defining opportunity: Shape the future of quality and regulatory excellence at a company known for its precision, trust, and commitment to patient care.

 

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