Manager, Medical Device Labeling and Operations

Regulatory Jobs; Texas; Remote; USD 120,000 - 145,000; Full time

Benefits offered by this job

Health benefits

401K/Retirement

Employee Stock Purchase Plan

Training & Education Assistance

Bonus Referral Program

Flexible Work Schedules

Personal and Vacation Time

Service Awards

Employee Recognition Program

Job summary

LivaNova is seeking a Regulatory Labeling & Operations Manager to own global labeling strategy for Neuromodulation therapies. You will drive compliant labeling across IFU, packaging, e-labeling, and software UI text while coordinating with Regulatory Affairs, Quality, R&D, Clinical, Marketing and Operations.

Responsibilities include leading EU MDR labeling initiatives, managing translation vendors, and supporting FDA and Notified Body audits.

Qualifications

• 8+ years in medical device labeling, regulatory affairs, or related function.
• Experience supporting Class III implantable systems.
• Strong knowledge of FDA (21 CFR 820), EU MDR, ISO 13485, and global labeling regulations.
• Experience with localization and translation management.
• Managing labeling lifecycle, UDI systems, and document control processes.
• Cross-functional collaboration and project leadership skills.

Responsibilities

• Own end-to-end labeling activities for Neuromodulation products, including updates and lifecycle maintenance.
• Lead EU MDR labeling activities, gap assessments, remediation plans, and implementation.
• Define and maintain global labeling strategies aligned with FDA, EU MDR, and international requirements.
• Lead translation and localization processes, including vendor management.
• Support internal and external audits (FDA, Notified Body, MDSAP).

Skills

Medical device labeling

Regulatory affairs

Localization management

Document control

Cross-functional collaboration

Project leadership

Education

Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a related field

Tools

MadCap Flare

Adobe Illustrator

Adobe InDesign

Job description

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives.

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.

General Responsibilities

This role leads and oversees end-to-end ownership of labeling activities, including sustaining labeling, compliance, UDI management, e-labeling, and localization. The role 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.

Labeling Strategy and Ownership

• 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

• 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

UDI Management and Labeling Operations

• Own and maintain UDI strategy and implementation across all therapies, including:
• DI/GTIN assignment and lifecycle management
• Compliance with FDA, EU MDR, and global UDI requirements
• Coordinate with Operations, IT, and Supply Chain to ensure successful labeling implementation
• Ensure labeling readiness within DMR, ERP, and document control systems

Labeling Verification and Requirements Management

• Define and oversee labeling verification and validation activities
• Ensure traceability between labeling content and system/product requirements
• Collaborate with QA and verification teams to ensure labeling accuracy and completeness
• Ensure labeling activities are fully integrated within design control and change management processes

E-Labeling and Digital Content Management

• Own and manage e-labeling platforms and website content
• Ensure compliance with global electronic labeling requirements
• Maintain version control and availability of approved labeling content
• Lead multi-channel labeling strategies (print and digital delivery)

Minimum Qualifications

• 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

Preferred Skills and Qualifications

• Experience in MadCap Flare (highly preferred)
• Experience with labeling systems (e.g., Loftware, NiceLabel are highly preferred)
• Experience with visual design of package labels using symbols from FDA recognized consensus standards and international standards.
• Experience or certification in Regulatory Affairs (e.g., RAC).
• Experience with Agile development methodologies.

Education

• Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a related field.

Location & Travel

• Available as a Remote role or based in our Houston, TX office
• This position may require occasional business travel of 20% or more of the time.

Pay Transparency

• A reasonable estimate of the annual base salary for this position is $120,000 - 145,000 plus discretionary annual bonus. Pay ranges may vary by location and are awarded based on experience.

Employee benefits include:

• 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

Valuing different backgrounds:

LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.