Manager, Regulatory Labeling and Operations

LivaNova

4d•$120,000 - $145,000•Remote

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

Leads and oversees end-to-end ownership of labeling activities, including sustaining labeling, compliance, UDI management, e-labeling, and localization.
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.
Owns end-to-end labeling activities for Neuromodulation product portfolios, including updates, remediation, and lifecycle maintenance.
Leads EU MDR labeling activities, including gap assessments, remediation plans, and implementation.
Defines and maintains global labeling strategies aligned with FDA, EU MDR, and international regulatory requirements.
Leads global translation and localization processes, including vendor management and oversight.
Supports internal and external audits (FDA, Notified Body, MDSAP).
Develops, reviews, and maintains product labeling documentation, including: Physician and Patient Instructions for Use (IFUs), Package labeling and implant cards, Software UI text and labeling content.
Ensures labeling aligns with product requirements, intended use, and regulatory standards.
Manages labeling review, approval, and release processes, ensuring accuracy and compliance.
Owns and maintains UDI strategy and implementation across all therapies, including DI/GTIN assignment and lifecycle management.
Ensures compliance with FDA, EU MDR, and global UDI requirements.
Coordinates with Operations, IT, and Supply Chain to ensure successful labeling implementation.
Ensures labeling readiness within DMR, ERP, and document control systems.
Defines and oversees labeling verification and validation activities.
Ensures traceability between labeling content and system/product requirements.
Collaborates with QA and verification teams to ensure labeling accuracy and completeness.
Ensures labeling activities are fully integrated within design control and change management processes.
Owns and manages e-labeling platforms and website content.
Ensures compliance with global electronic labeling requirements.
Maintains version control and availability of approved labeling content.
Leads multi-channel labeling strategies (print and digital delivery).