Remote Global Medical Device Labeling & Ops Lead

LivaNova; United States; Remote; USD 120,000 - 145,000; Full time

Benefits offered by this job

Health benefits

401K

Employee Stock Purchase Plan

Training & Education Assistance

Bonus Referral Program

Service Awards

Flexible Work Schedules

Job summary

LivaNova seeks a Regulatory Labeling & Operations Manager to lead global labeling for Neuromodulation therapies. You will own end-to-end labeling activities (IFUs, packaging, e-labeling, UDI) and ensure regulatory compliance across markets.

You will collaborate with Regulatory Affairs, Quality, R&D, Clinical, Marketing and Operations to support development, global submissions and post-market activities, while driving scalable labeling processes and localization with vendors.

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.
• Experience with localization and translation management.
• Experience managing labeling lifecycle, UDI systems, and document control processes.

Responsibilities

• Own end-to-end labeling activities for Neuromodulation product portfolios, including updates and lifecycle maintenance.
• Lead EU MDR labeling activities, gap assessments and implementation.
• Define and maintain global labeling strategies with FDA, EU MDR and international requirements.
• Lead global translation and localization processes with vendor oversight.
• Coordinate with QA, design control and change management to ensure labeling accuracy.

Skills

Regulatory labeling

Medical device labeling

Regulatory affairs

Vendor management

Localization management

MadCap Flare

Adobe Illustrator

Adobe InDesign

Cross-functional leadership

Education

Bachelor's degree

Tools

MadCap Flare

Loftware

NiceLabel

Adobe Illustrator

Adobe InDesign

Job description

LivaNova seeks a Regulatory Labeling & Operations Manager to lead global labeling for Neuromodulation therapies. You will own end-to-end labeling activities (IFUs, packaging, e-labeling, UDI) and ensure regulatory compliance across markets.

You will collaborate with Regulatory Affairs, Quality, R&D, Clinical, Marketing and Operations to support development, global submissions and post-market activities, while driving scalable labeling processes and localization with vendors.