Medical Device Technical Writer / Technical Publications Specialist (IFU focus)
説明
今すぐ私たちと一緒に、人々の人生に変化をもたらしましょう！
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.
Job Summary
LivaNova is seeking an experienced technical writer / technical publications specialist to develop and maintain critical product labeling documentation, with a strong emphasis on Instructions for Use (IFUs) and other user-facing materials for our medical devices and accessories. This role demands proven expertise in creating clear, accurate, and user-friendly documentation using MadCap Flare as the primary information development tool. The ideal candidate will have a strong technical writing background specific to medical device IFUs, excellent collaboration skills, and a meticulous approach to ensuring regulatory compliance and high-quality deliverables.
Primary Activities
Develop and maintain product labeling documentation for medical devices, including Physician and Patient Instructions for Use (IFUs), Quick Reference Guides, and training materials.
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 review and approval process of IFUs and associated materials, incorporating feedback from stakeholders and ensuring timely completion of documentation milestones within project timelines.
Maintain a thorough understanding of our medical device products, their design, functionality, and intended clinical applications.
Expertly utilize information development tools, with primary emphasis on MadCap Flare, along with Adobe Illustrator and Adobe InDesign, to create visually engaging, well-structured, and user-friendly documentation.
Develop and maintain labeling templates and style guides within MadCap Flare and other relevant tools to ensure consistency, clarity, and adherence to brand guidelines across all labeling materials.
Perform copywriting, editing and maintenance of user interface content within medical device software.
Proactively manage labeling updates and revisions, ensuring strict adherence to version control procedures and accurate documentation in the electronic document management system (EDMS), IQVIA SmartSolve.
Contribute to the development and improvement of labeling processes and procedures.
Coordinates / performs web posting of approved labeling.
Performs other duties as may be required by management.
Travel Requirements
This position may require occasional business travel of 10% or more of the time.
Qualifications
Bachelor's degree in Technical Communication, English, Science, Engineering, or a related discipline.
A minimum of 5 years of progressive experience in technical writing, specifically in the medical device industry, with a significant focus on developing Instructions for Use (IFUs).
Proven expert-level proficiency in using MadCap Flare for single-source publishing and managing complex documentation projects.
In-depth and current understanding of medical device labeling regulations, including FDA 21 CFR Part 801 and EU MDR 2017/745.
Demonstrated experience in formulating and executing comprehensive labeling plans.
Exceptional writing, editing and proofreading skills with meticulous attention to detail and a strong focus on clarity and accuracy in technical documentation.
Proven ability to interpret and effectively communicate complex technical and clinical information to a variety of audiences.
Extensive experience working collaboratively with cross-functional teams in a highly regulated environment.
Strong familiarity with electronic document management systems (EDMS); direct experience with IQVIA SmartSolve is highly preferred.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Experience with graphics software (e.g., Adobe Illustrator) and desktop publishing software (e.g., Adobe InDesign) for integrating visuals into technical documentation.
Excellent communication, interpersonal, and collaboration skills, with the ability to effectively influence and negotiate.
Strong organizational and project management skills, with the ability to manage multiple projects simultaneously and meet deadlines.
Preferred Qualifications
Experience managing translation workflows and working with translation vendors.
Familiarity with e-labeling requirements.
Pay Transparency
A reasonable estimate of the annual base salary for this position is $90,000 - $115,000 plus discretionary annual bonus. Pay ranges may vary by location and will be 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
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LivaNovaは平等を重視し、多様性を称えます。私たちは、弊社の採用プロセスが公正で透明性があり、不法な差別がないように尽力しています。
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LivaNovaは、現地の法律の許可範囲内で、雇用される可能性のある方に対してバックグラウンド調査および/またはリファレンスチェックを行うことに同意を求めます。
したがって、このオファーについては、このようなバックグラウンド調査および/またはリファレンスチェックの同意を条件とし、バックグラウンドチェックの各要件について協力し調査をした結果
または拒否した結果によって現地の法律で認められている範囲内で内定または雇用の取消に影響いたしますことをご了承ください。
第三者業者への通知：
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