Manager, Regulatory Labeling and Operations

General Responsibilities

• Lead and oversee end-to-end ownership of labeling activities, including sustaining labeling, compliance, UDI management, e-labeling, and localization.
• Ensure 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 compliance.

UDI 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.
• Cook 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 processes.

E-Labeling and Digital Content Management

• Own and manage e-labeling platforms and website content.
• Maintain 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.
• 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.

Preferred Skills And Qualifications

• 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.