Hiring: Manager - Quality & Regulatory Affairs Company: Nobel Biocare Location: Lubbock, TX Job Posted Time: 2026-09-03 10:36:35 Employment Type: Contract Target Skills & Keywords : R, Regulatory Compliance About the job Experience: •5+ years of experience in medical device regulatory affairs, with exposure to quality systems Required Skills: •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. Qualifications: •Bachelor’s degree in scientific or technical discipline •Strong working knowledge of medical device regulations and quality systems (e.g., 21 CFR 820, QMSR, ISO 13485, MDD & EU MDR). •Demonstrated experience leading regulatory strategies and interacting with global regulatory authorities. •RAPS certification or formal regulatory training are preferred. •Excellent critical thinking, problem‑solving, and decision‑making skills. •Strong written and verbal communication skills with the ability to influence at multiple organizational levels. •Proven ability to work independently, manage multiple priorities, and lead cross‑functional collaboration. •Envista and all Envista Companies are Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!