Job Overview
Location
US_Remote
Job Type
Full-time
Category
Product Management
Date Posted
July 9, 2026
Full Job Description
đź“‹ Description
- • The Regulatory Labeling & Operations Manager is responsible for the development, implementation, and oversight of global product labeling strategy and operations for Neuromodulation therapies.
- • This role is critical in ensuring our products are safely and effective for use, while meeting regulatory requirements.
- • The position requires a strong knowledge of medical device regulations, excellent writing and communication skills, and experience in labeling development, localization, and vendor management.
- • The position partners closely with Regulatory Affairs, Quality, R&D, Clinical, Marketing and Operations to support sustaining product development, global submissions, and post-market activities.
- • Leads and oversees end-to-end ownership of labeling activities, including sustaining labeling, compliance, UDI management, e-labeling, and localization.
- • Ensures all labeling (IFU, packaging labels, e-labeling, and software UI text) is accurate, compliant, and aligned with global regulatory requirements, while also driving scalable processes across UDI, localization, and labeling operations.
- • Owns end-to-end labeling activities for Neuromodulation product portfolios, including updates, remediation, and lifecycle maintenance.
- • Leads EU MDR labeling activities, including gap assessments, remediation plans, and implementation.
- • Defines and maintains global labeling strategies aligned with FDA, EU MDR, and international regulatory requirements.
- • Leads global translation and localization processes, including vendor management and oversight.
- • Supports internal and external audits (FDA, Notified Body, MDSAP).
- • Develops, reviews, and maintains product labeling documentation, including Physician and Patient Instructions for Use (IFUs), package labeling and implant cards, software UI text and labeling content.
- • Ensures labeling aligns with product requirements, intended use, and regulatory standards.
- • Manages labeling review, approval, and release processes, ensuring accuracy and compliance.
- • Owns and maintains UDI strategy and implementation across all therapies, including DI/GTIN assignment and lifecycle management, compliance with FDA, EU MDR, and global UDI requirements.
- • Coordinates with Operations, IT, and Supply Chain to ensure successful labeling implementation.
- • Ensures labeling readiness within DMR, ERP, and document control systems.
- • Defines and oversees labeling verification and validation activities.
- • Ensures traceability between labeling content and system/product requirements.
- • Collaborates with QA and verification teams to ensure labeling accuracy and completeness.
- • Ensures labeling activities are fully integrated within design control and change management processes.
- • Owns and manages e-labeling platforms and website content.
- • Ensures compliance with global electronic labeling requirements.
- • Maintains version control and availability of approved labeling content.
- • Leads multi-channel labeling strategies (print and digital delivery).
🎯 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.
Skills & Technologies
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About LivaNova PLC
LivaNova PLC is a global medical technology company focused on developing and delivering innovative therapies for cardiovascular and neurological conditions. The company operates through two primary segments: Cardiovascular, which includes heart valve therapies, circulatory support, and perfusion systems; and Neuromodulation, which offers implantable devices for treating epilepsy, depression, and chronic pain via vagus nerve stimulation. Headquartered in London with operational hubs in the U.S. and Europe, LivaNova serves hospitals and clinicians worldwide, combining advanced engineering with clinical expertise to improve patient outcomes. The company emphasizes research-driven innovation, regulatory excellence, and sustainable growth in the global medtech industry.
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