Manager, Regulatory Labeling and Operations

LivaNova

Regulatory Labeling & Operations Manager at medtech company handling Neuromodulation product labeling activities. Ensuring compliance with FDA and international labeling regulations and leading cross-functional collaborations.

Posted 7/6/2026full-timeRemote • Texas • 🇺🇸 United StatesSeniorLead💰 $120,000 - $145,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive experience in medical device labeling and regulatory affairs, with a strong focus on FDA and EU MDR compliance. Capable of managing end-to-end labeling processes, including UDI strategy and cross-functional collaboration.

Highest-signal resume keywords

Medical Device LabelingRegulatory AffairsFDA ComplianceEU MDR KnowledgeLabeling Lifecycle Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Labeling Documentation DevelopmentGap AssessmentRemediation PlanningLabeling VerificationUDI ImplementationDocument Control Processes

Soft Skills

Cross-Functional CollaborationProject Leadership

Tools & Technologies

MadCap FlareAdobe IllustratorAdobe InDesign

Industry Keywords

Class III Medical Implantable SystemsISO 13485MDSAPGlobal Labeling Regulations

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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