Livanova
Manager, Regulatory Labeling and Operations
US_Remote, USA
Sponsorship not specified$120k-$145kDetected 15 days ago
IllustratorSupply ChainVendor ManagementERPControlsFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationWritingRegulatory Affairs
About the role
- 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.
- The Regulatory Labeling & Operations Manager is responsible for the development, implementation, and oversight of global product labeling strategy and operations for Neuromodulation therapies.
Responsibilities
- 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)
- Manage labeling review, approval, and release processes, ensuring accuracy and compliance
Requirements
- 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 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.
Nice to have
- Experience in MadCap Flare (highly preferred)
- Experience with labeling systems (e.g., Loftware, NiceLabel are highly preferred)
Compensation
- 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.
- In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee.
Company info
- 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.
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