Remote Global Labeling & Regulatory Operations Lead

LivaNova; Town of Texas (WI); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Health benefits

401(k) retirement plan

Employee stock purchase plan

Training & Education Assistance

Flexible work schedules

Bonus referral program

Job summary

LivaNova is seeking an experienced Regulatory Labeling & Operations Manager to lead global labeling strategy for Neuromodulation therapies. The role oversees labeling development, localization, and UDI management, partnering across Regulatory Affairs, QA, R&D, and Operations.

The candidate will drive compliant labeling across FDA and EU MDR, coordinate translations, oversee e-labeling, and ensure readiness for audits and post-market activities.

Qualifications

• 8+ years in medical device labeling or regulatory affairs.
• Experience with Class III implantable systems preferred.
• Familiarity with FDA (21 CFR Part 820), EU MDR, ISO 13485.

Responsibilities

• Own end-to-end labeling activities including updates and lifecycle maintenance.
• Lead EU MDR labeling activities and remediation plans.
• Define global labeling strategies aligned with regulatory requirements.
• Lead translation/localization and vendor management.
• Support internal and external audits (FDA, Notified Bodies, MDSAP).

Skills

Medical labeling

Regulatory affairs

FDA/EU MDR knowledge

Localization management

UDI systems

Document control

MadCap Flare

Adobe Illustrator

Adobe InDesign

Agile methods

Education

Bachelor's degree in Technical Writing/English/Communications

Tools

MadCap Flare

Loftware

NiceLabel

Adobe Illustrator

Adobe InDesign

ERP systems

Job description

LivaNova is seeking an experienced Regulatory Labeling & Operations Manager to lead global labeling strategy for Neuromodulation therapies. The role oversees labeling development, localization, and UDI management, partnering across Regulatory Affairs, QA, R&D, and Operations.

The candidate will drive compliant labeling across FDA and EU MDR, coordinate translations, oversee e-labeling, and ensure readiness for audits and post-market activities.