Hiring: Manager, Medical Device Labeling and Operations Company: LivaNova Location: Texas, United States Job Posted Time: 2026-09-10 11:23:12 Employment Type: Remote Target Skills & Keywords : Agile, Change Management, R, Requirements Management, Vendor Management About the job Experience: •8+ years of experience in medical device labeling, regulatory affairs, or related function Required Skills: •Own end-to-end labeling activities for Neuromodulation product portfolios, including updates, remediation, and lifecycle maintenance •Lead EU MDR labeling activities, including gap assessments, remediation plans, and implementation •Define and maintain global labeling strategies aligned with FDA, EU MDR, and international regulatory requirements •Lead global translation and localization processes, including vendor management and oversight •Support internal and external audits (FDA, Notified Body, MDSAP) •Label Development and Compliance •Physician and Patient Instructions for Use (IFUs) •Package labeling and implant cards Qualifications: •Strong knowledge of FDA (21 CFR Part 820), EU MDR, ISO 13485, and global labeling regulations, preferably MDSAP countries •Strong cross-functional collaboration and project leadership skills •Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a related field. •Available as a Remote role or based in our Houston, TX office Compensation: •$120,000 - $145,000 / year •Flexible work environment (work from home / hybrid options) •A reasonable estimate of the annual base salary for this position is $120,000 - 145,000 plus discretionary annual bonus 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!