Manager - Quality & Regulatory Affairs

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 is a pioneer in dental osteotomy and bone densification technologies and is now part of Nobel Biocare, a global implant and regenerative solutions leader within the Envista family of brands. Powered by its patented Densah® Bur technology and Osseodensification® approach, Versah helps clinicians worldwide enhance implant site preparation and regenerative procedures.This role supports global regulatory compliance while contributing to the maintenance and continuous improvement of the Quality Management System. It is well suited for a highly coachable regulatory professional with a solid RA foundation and working knowledge of quality systems who is eager to expand into broader quality system ownership over time.Success in this role means enabling global market access while maintaining audit-ready compliance, and it offers a strong opportunity to join a collaborative team and grow into increased ownership and leadership over time.

Duties and responsibilities:

• Develop and lead global regulatory strategies to secure and maintain approvals for Versah’s medical device portfolio, with primary ownership of emerging markets.
• Interpret global and regional regulations and translate them into clear product, project, and business requirements across the full product lifecycle.
• Prepare, submit, and maintain international regulatory filings; serve as the primary contact for health authorities, including negotiation and timely resolution of regulatory questions.
• Provide regulatory guidance to cross-functional partners (R&D, Engineering, Quality, Operations, Marketing, and Sales) to support both new product development and sustaining activities.
• Ensure alignment with Envista and Nobel Biocare regulatory and quality frameworks, and drive maintenance and continuous improvement of the Versah Quality Management System in accordance with applicable regulations and standards.
• Support and participate in external, third-party, and regulatory audits/inspections in collaboration with Regulatory and Quality leadership.
• Support supplier qualification, incoming inspection/material review, and nonconformance management; support complaint investigations and CAPA; and maintain product traceability, quality records, and document control.
• Oversee import/export regulatory compliance and ensure adherence to country-specific requirements for product distribution.
• Manage and maintain global UDI compliance across all applicable markets.
• Conduct regulatory assessments to inform business planning, market expansion, and product lifecycle decisions.
• Monitor, interpret, and communicate changes in global medical device regulations to drive ongoing compliance and organizational awareness.