Manager, Regulatory Labeling and Operations

🕒 July 6

🤠 Texas – Remote

🤠 Texas – Remote

💵 $120k - $145k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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LivaNova

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏭 Manufacturing

🏥 Healthcare

🧬 Biotechnology

Manufacturing • Healthcare • Biotechnology

LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. With a focus on medical devices, neuromodulation, and cardiac surgery, LivaNova offers advanced technologies and breakthrough treatments that provide meaningful solutions for patients, healthcare professionals, and healthcare systems. Headquartered in London and active in over 100 countries, LivaNova emphasizes bringing both clinical and economic value to its customers, being recognized as a market leader in cardiopulmonary and neuromodulation solutions.

📋 Description

• 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) • Develop, review, and maintain product labeling documentation, including Physician and Patient Instructions for Use (IFUs), Package labeling and implant cards, Software UI text and labeling content • Ensure labeling aligns with product requirements, intended use, and regulatory standards • Manage labeling review, approval, and release processes, ensuring accuracy and compliance • Own and maintain UDI strategy and implementation across all therapies, including DI/GTIN assignment and lifecycle management • Coordinate with Operations, IT, and Supply Chain to ensure successful labeling implementation • Define and oversee labeling verification and validation activities • Collaborate with QA and verification teams to ensure labeling accuracy and completeness

🎯 Requirements

• 8+ years of experience in medical device labeling, regulatory affairs, or related function • Experience supporting Class III medical implantable systems • Strong knowledge of FDA (21 CFR Part 820), EU MDR, ISO 13485, and global labeling regulations, preferably MDSAP countries • Experience working with information development tools, such as MadCap Flare, Adobe Illustrator, and Adobe InDesign • Experience with localization and translation management • Experience managing labeling lifecycle, UDI systems, and document control processes • Strong cross-functional collaboration and project leadership skills

🏖️ Benefits

• Health benefits – Medical, Dental, Vision • Personal and Vacation Time • Retirement & Savings Plan (401K) • Employee Stock Purchase Plan • Training & Education Assistance • Bonus Referral Program • Service Awards • Employee Recognition Program • Flexible Work Schedules