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 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 • 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 processes E-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 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. Education • Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a related field. Location & Travel • Available as a Remote role or based in our Houston, TX office • This position may require occasional business travel of 20% or more of the time. Pay Transparency • A reasonable estimate of the annual base salary for this position is $120,000 - 145,000 plus discretionary annual bonus. Pay ranges may vary by location and are awarded based on experience. Employee benefits include: • Health benefits - Medical, Dental, Vision • Personal and Vacation Time • Retirement & Savings Plan (401K) • Employee Stock Purchase Plan • Training & Education Assistance • Bonus Referral Program • Service Awards • Employee Recognition Program • Flexible Work Schedules