Global Regulatory & Quality Lead - Med Device

Nobel Biocare; Lubbock (TX); On-site; USD 120,000 - 190,000; Full time

Job summary

Nobel Biocare, a global implant and regenerative solutions leader within Envista, seeks a regulatory affairs professional to lead global regulatory strategies for Versah’s medical device portfolio, with primary ownership of emerging markets.

You will interpret regulations, prepare filings, and act as the primary contact for health authorities, while guiding R&D, Engineering, Quality, Operations, Marketing, and Sales to sustain the product lifecycle and maintain audit-ready compliance.

Qualifications

• Bachelor’s degree in scientific or technical discipline.
• 5+ years in medical device regulatory affairs with exposure to quality systems.
• Strong knowledge of medical device regulations and quality systems (e.g., 21 CFR 820, QMSR, ISO 13485, EU MDR).
• Demonstrated experience leading regulatory strategies and interacting with global regulatory authorities.
• RAPS certification or formal regulatory training preferred.

Responsibilities

• Develop and lead global regulatory strategies 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.

Education

Bachelor’s degree in scientific or technical discipline

Job description

Nobel Biocare, a global implant and regenerative solutions leader within Envista, seeks a regulatory affairs professional to lead global regulatory strategies for Versah’s medical device portfolio, with primary ownership of emerging markets.

You will interpret regulations, prepare filings, and act as the primary contact for health authorities, while guiding R&D, Engineering, Quality, Operations, Marketing, and Sales to sustain the product lifecycle and maintain audit-ready compliance.