Global Labeling & Compliance Lead – Medical Devices (Remote)

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

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.