Manager, Medical Device Labeling and Operations

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, Liva Nova is where your talent can truly thrive.

Join our talented team members worldwide to become a pioneer of tomorrow—because at Liva Nova, 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 complianceUDI 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 processesE-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 Mad Cap Flare, Adobe Illustrator, and Adobe InDesign.

Experience with localization and…