Technical Writer / Labeling Specialist (Medical Devices)

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LivaNova is a global medical technology company built on nearly five decades of experience and a relentless commitment to improving the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals, and healthcare systems.  The company is listed on the NASDAQ stock exchange under the ticker symbol “ LIVN .”  LivaNova is headquartered in London (UK) with a presence in over 100 countries and a team of more than 3,000 employees worldwide.

This position is responsible for the development, implementation, and maintenance of product labeling for Neuromodulation Business Unit products. This position reports to the Manager, Clinical Engineering, and Labeling.

Job Summary

LivaNova is seeking a highly skilled and experienced Technical Writer/Labeling Specialist to develop, implement, and maintain product labeling for our medical devices. This role is critical in ensuring our products are safely and effectively used by healthcare professionals and patients, while also meeting stringent regulatory requirements. The successful candidate will have a strong understanding of medical device regulations, excellent writing and communication skills, and proficiency in industry-standard information development tools. This role also includes localization of content and management of translation vendors.

PRIMARY ACTIVITIES

• Develop and maintain all product labeling documentation for medical devices, including but not limited to:

  • Physician Instructions for Use (IFUs)

  • Patient Instructions for Use (IFUs)

  • Quick Reference Guides

  • Training Materials

  • Packaging Labels

• Ensure all labeling complies with relevant regulatory requirements, including FDA (21 CFR Part 820), EU MDR, and other applicable international standards.

• Collaborate closely with cross-functional teams, including Regulatory, R&D, Marketing, Quality, and Clinical, to gather information and ensure accuracy of labeling content.

• Manage the labeling review and approval process, incorporating feedback from stakeholders and ensuring timely completion.

• Maintain a thorough understanding of product design, functionality, and clinical applications.

• Utilize information development tools, including MadCap Flare, Adobe Illustrator, and Adobe InDesign, to create visually appealing and user-friendly documentation.

• Develop and maintain labeling templates and style guides to ensure consistency and brand alignment.

• Manage the localization process for all labeling materials, including translation, review, and validation.

• Work with translation vendors to create, apply, and maintain translation memories, glossaries, and style guides.

• Ensure the quality and accuracy of translated materials.

• Manage labeling updates and revisions, ensuring proper version control and documentation in the electronic document management system.

• Contribute to the development and improvement of labeling processes and procedures.

• Contribute to user interface text within the medical device software and manage its translation.

• Coordinates / performs web posting of approved labeling.

MINIMUM REQUIREMENTS AND QUALIFICATIONS

• Bachelor's degree in Technical Writing, English, Communications, a scientific discipline, or a related field.

• 5-7 years of experience in technical writing, preferably in the medical device industry.

• Proven experience developing labeling for Class III implantable medical devices or Connected Care products.

• Strong understanding of medical device regulations (FDA 21 CFR Part 820, EU MDR, ISO 13485, etc.).

• Expertise in information development tools, including MadCap Flare, Adobe Illustrator, and Adobe InDesign.

• Experience with localization and translation management.

• Excellent communication and interpersonal skills.

PREFERRED SKILLS AND QUALIFICATIONS

• Experience with visual design of package labels using symbols from FDA recognized consensus standards and international standards.

• Experience with Loftware Cloud platform.

• Content management systems (CMS) and XML authoring.

• Experience with Regulatory Affairs or certification (e.g., RAC).

• Publication and maintenance of electronic labeling.

• Agile development methodologies.

• Experience with copywriting and long-form prose

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