Product Information Team Lead

Work Schedule

Environmental Conditions

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 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

• Bachelors or Masters degree in Technical Communication English Journalism Life Sciences (e.g. Biology Biochemistry Molecular Biology) or a related field; equivalent experience will be considered.
• 58 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.