Manager, Regulatory Labeling and Operations

🔥 0 minutes ago

🤠 Texas – Remote

🤠 Texas – Remote

💵 $120k - $145k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🚔 Compliance

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LivaNova

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

LivaNova PLC 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. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems.

📋 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