Job Description :
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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.
