Product Information Team Lead

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p><b>Position Summary</b></p><p>We are seeking an experienced <b>Product Information Team Lead</b> to provide direction and oversight for a group of IFU writers, manuals writers, and label creators. In this role, you will lead the creation of high-quality, compliant, and user-focused product information. You will serve as a key liaison between cross-functional teams and external partners while ensuring all documentation aligns with regulatory and quality standards.</p><p></p><p><b>Key Responsibilities</b></p><ul><li><b>Lead and mentor</b> a team of IFU writers, manuals writers, and label creators; provide guidance, training, and performance feedback.</li><li><b>Represent the team</b> in cross-functional projects, management meetings, act as the primary contact for external sites.</li><li><b>Drive team activities</b> and deliverables within the defined scope of responsibility, ensuring timelines and quality expectations are met.</li><li><b>Create, revise and publish</b> high-quality <b>Instructions for Use (IFU)</b> and <b>User manuals </b>in accordance with current routines &amp; processes, regulatory, design, environmental and market requirements</li><li><b>Ensure compliance</b> with QSR, ISO, and internal quality procedures, as well as relevant regulatory frameworks (e.g., IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485).</li><li><b>Manage and coordinate translations </b>to ensure accuracy and consistency.</li><li><b>Collaborate with global cross-functional teams</b> (Product Development, Regulatory Affairs, Quality Assurance, Marketing, and Operations) to gather input and validate content.</li><li><b>Continuously improve documentation standards, templates, and processes</b> to enhance quality and efficiency.</li><li><b>Support quality investigations</b>, including deviations, CAPAs, and complaints, as needed.</li></ul><p></p><p><b>Qualifications and Experience</b></p><ul><li>Bachelor’s or Master’s degree in <b>Technical Communication, English, Journalism, Life Sciences</b> (e.g., Biology, Biochemistry, Molecular Biology), or a related field; equivalent experience will be considered.</li><li><b>5–8 years of technical writing experience</b> within the life sciences, medical device, or in vitro diagnostics (IVD) industries.</li><li>Proven expertise in developing <b>IFUs, DFUs, product labels, and user manuals</b> that meet international regulatory requirements.</li><li>Strong understanding of <b>regulated content development</b>, usability, and risk communication principles.</li><li>Experience from working with <b>translations and simplified English.</b></li><li>Familiarity with <b>visual and multimedia tools</b> (e.g., Adobe Illustrator or similar) for producing clear and user-friendly illustrations.</li><li>Demonstrated ability to <b>manage multiple global projects</b> in a fast-paced, regulated environment.</li><li>Prior <b>training in QSR</b>; experience with <b>EU IVDR / MDR</b> is a plus.</li><li><b>Excellent English,</b> including speaking, writing and editing skills.</li></ul><p></p><p><b>Preferred Skills</b></p><ul><li>Proven ability to create <b>clear, compliant, and user-focused documentation</b> for laboratory technicians, clinicians, and regulatory reviewers.</li><li><b>Multilingual communication skills</b> (e.g., German, French, Spanish) to support global localization efforts.</li><li>Experience in use of <b>reusable content strategies</b> to drive consistency and efficiency.</li><li>Strong <b>cross-cultural collaboration skills</b>, adaptability, and the ability to work effectively in global teams.</li><li>Exceptional <b>attention to detail, scientific accuracy</b>, and commitment to continuous improvement.</li><li>Excellent interpersonal and communication skills, fostering strong collaboration across functions.</li><li>Experience with <b>EU MDR</b> documentation requirements is a plus.</li></ul><p></p><p></p><p></p><p></p>