Global Regulatory Lead, Medical Devices

Envista Holdings Corporation; Texas; Hybrid; USD 150,000 - 190,000; Full time

Job summary

Versah, LLC, part of the Envista family, seeks a Regulatory Affairs professional to lead global strategies for the medical device portfolio. You will prepare and maintain international filings, serve as the primary contact for health authorities, and guide R&D, Quality, and Operations to ensure compliant product development and sustaining activities.

This role focuses on expanding regulatory ownership over time, achieving audit-ready compliance, and contributing to market access across regions

Qualifications

• Bachelor’s degree in scientific or technical discipline
• 5+ years of experience in medical device regulatory affairs
• Strong knowledge of medical device regulations and quality systems

Responsibilities

• Develop and lead global regulatory strategies for medical devices
• Prepare, submit, and maintain international filings
• Provide regulatory guidance to cross-functional partners (R&D, Engineering, Quality, Operations, Marketing, and Sales)
• Ensure alignment with Envista and Nobel Biocare regulatory and quality frameworks
• Support audits/inspections, CAPA and document control

Skills

Regulatory affairs

Critical thinking

Communication

Problem solving

Decision making

Education

Bachelor’s degree in scientific or technical discipline

Job description

Versah, LLC, part of the Envista family, seeks a Regulatory Affairs professional to lead global strategies for the medical device portfolio. You will prepare and maintain international filings, serve as the primary contact for health authorities, and guide R&D, Quality, and Operations to ensure compliant product development and sustaining activities.

This role focuses on expanding regulatory ownership over time, achieving audit-ready compliance, and contributing to market access across regions