New · posted Oct 15
LivaNova · Medical Devices
Manager, Medical Device Labeling and Operations
- Remote, Texas, US
- Remote
- Full-time
- Manager
Open until filled
The role
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.
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
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)
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.
What you need
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
Education
Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a related field.
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
Preferred Skills and Qualificationsnice to have
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.
What you'll do
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.
Pay and benefits
$120,000 a year
Employer providedPay 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
Working conditions
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.
Equal opportunity, accessibility and legal noticesLivaNova's statements, word for word
Notice to third party agencies
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.
Beware of Job Scams
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 https://www.livanova.com/en-us/careers, and check that all recruitment emails come from an @livanova.com email address.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 20% below the US median for Labeling & Promotion roles at this level.
This roleEmployer provided
Manager roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $120,000 | — | $120,000 |
| All US (middle half) | $143,000 | $149,500 | $172,250 |
This role: LivaNova's own published range. Comparisons: the base pay employers published on open Labeling & Promotion roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Labeling & Promotion
The general path across 74 open Labeling & Promotion roles on Regulatory Jobs, with the titles they carry most. Not LivaNova's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 42 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Regulatory submissions26
- Collaboration and leadership9
- GMP and compliance7
- Documentation and SOPs5
- Data and digital systems2
- Lab testing and methods1
- Validation and qualification1
- Quality systems and risk1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
LivaNova on Regulatory Jobs
- 3
- Open roles
- 3
- Distinct roles
- 2
- Locations
By discipline
- Quality2 67%
- Regulatory1 33%
By level
- Manager1 33%
- Senior & Principal1 33%
- Associate & Specialist1 33%
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Manager, Medical Device Labeling and Operations at LivaNova
Open until filled. $120K a year, employer provided.