Global Regulatory Affairs & Quality Lead — MedTech

Envista; Lubbock (TX); On-site; USD 90,000 - 150,000; Full time

Job summary

Versah, LLC, part of the Nobel Biocare/Envista family, seeks a regulatory professional to lead global compliance while strengthening the Quality Management System. You will collaborate with R&D, Engineering, Quality, Operations, Marketing, and Sales to align regulatory plans with product lifecycle goals.

The role emphasizes expanding ownership over time, ensuring audit-ready processes, and enabling global market access for Versah’s dental devices.

Qualifications

• Solid regulatory affairs foundation and working knowledge of quality systems.
• Experience with global regulatory compliance and submissions is preferred.

Responsibilities

• Develop and lead global regulatory strategies for Versah’s medical device portfolio.
• Interpret global/regional regulations and translate them into product and lifecycle requirements.
• Prepare, submit, and maintain international regulatory filings; act as primary contact for health authorities.

Skills

Regulatory affairs

Quality systems

Audit readiness

Job description

Versah, LLC, part of the Nobel Biocare/Envista family, seeks a regulatory professional to lead global compliance while strengthening the Quality Management System. You will collaborate with R&D, Engineering, Quality, Operations, Marketing, and Sales to align regulatory plans with product lifecycle goals.

The role emphasizes expanding ownership over time, ensuring audit-ready processes, and enabling global market access for Versah’s dental devices.