Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Position Summary

We are seeking an experienced Product Information Team Lead 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.

Key Responsibilities

• Lead and mentor a team of IFU writers, manuals writers, and label creators; provide guidance, training, and performance feedback.
• Represent the team in cross-functional projects, management meetings, act as the primary contact for external sites.
• Drive team activities and deliverables within the defined scope of responsibility, ensuring timelines and quality expectations are met.
• Create, revise and publish high-quality **Instructions for Use (IFU)**and **User manuals **in accordance with current routines & processes, regulatory, design, environmental and market requirements
• Ensure compliance with QSR, ISO, and internal quality procedures, as well as relevant regulatory frameworks (e.g., IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485).
• Manage and coordinate translations to ensure accuracy and consistency.
• Collaborate with global cross-functional teams (Product Development, Regulatory Affairs, Quality Assurance, Marketing, and Operations) to gather input and validate content.
• Continuously improve documentation standards, templates, and processes to enhance quality and efficiency.
• Support quality investigations, including deviations, CAPAs, and complaints, as needed.

Qualifications and Experience

• Bachelor’s or Master’s degree in Technical Communication, English, Journalism, Life Sciences (e.g., Biology, Biochemistry, Molecular Biology), or a related field; equivalent experience will be considered.
• 5–8 years of technical writing experience within the life sciences, medical device, or in vitro diagnostics (IVD) industries.
• Proven expertise in developing IFUs, DFUs, product labels, and user manuals that meet international regulatory requirements.
• Strong understanding of regulated content development, usability, and risk communication principles.
• Experience from working with translations and simplified English.
• Familiarity with visual and multimedia tools (e.g., Adobe Illustrator or similar) for producing clear and user-friendly illustrations.
• Demonstrated ability to manage multiple global projects in a fast-paced, regulated environment.
• Prior training in QSR; experience with EU IVDR / MDR is a plus.
• Excellent English, including speaking, writing and editing skills.

Preferred Skills

• Proven ability to create clear, compliant, and user-focused documentation for laboratory technicians, clinicians, and regulatory reviewers.
• Multilingual communication skills (e.g., German, French, Spanish) to support global localization efforts.
• Experience in use of reusable content strategies to drive consistency and efficiency.
• Strong cross-cultural collaboration skills, adaptability, and the ability to work effectively in global teams.
• Exceptional attention to detail, scientific accuracy, and commitment to continuous improvement.
• Excellent interpersonal and communication skills, fostering strong collaboration across functions.
• Experience with EU MDR documentation requirements is a plus.