Vice President, Quality Assurance & Regulatory Affairs

Vice President, Quality Assurance & Regulatory Affairs

Job Function : Patient Health & Regulatory Affairs

Location : Auburn, MA, US, 01501; Charlton, MA, US, 01507; El Segundo, CA, US, 90245

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 :

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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MA Applicants : It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing / health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing / health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.

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