LivaNova · Remote · United States
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, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, 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.
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.
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)
Develop, review, and maintain product labeling documentation, including:
Physician and Patient Instructions for Use (IFUs)
Ensure labeling aligns with product requirements, intended use, and regulatory standards
Manage labeling review, approval, and release processes, ensuring accuracy and compliance
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
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
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)
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
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.
Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a related field.
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.
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.
Health benefits – Medical, Dental, Vision
LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.
Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.
Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons posing as LivaNova recruiters or employees. The scammers may attempt to solicit confidential, personal information, such as a social security number, or your financial information. LivaNova will never ask for fees prior/during/after the application process, nor will we ask for banking details or personal financial information in return for the assurance of employment. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for “See Open Jobs” on , and check that all recruitment emails come from an @livanova.com email address.
Originally posted on Himalayas