Technical Writer - IfU

• Create, revise, and publish high-quality Instructions for Use (IFU) in alignment with current procedures, regulatory expectations, and market needs.
• Ensure documentation complies with QSR, ISO, and other internal quality and regulatory standards.
• Coordinate translation activities with external translation agencies and internal stakeholders to ensure linguistic accuracy and timely delivery.
• Maintain adherence to company style guides, templates, and quality management systems (QMS).
• Collaborate cross-functionally with teams such as Product Development, Regulatory Affairs, Quality Assurance, Marketing, and Global Operations to gather information and validate technical accuracy.
• Drive and manage activities within the assigned area of responsibility.
• Contribute to the continous improvement of documentation standards, templates, and processes.
• Support Deviation, CAPA, and complaint investigations by providing documentation expertise and contributing to corrective action processes.

• Bachelor’s or Master’s degree in Technical Communication, English, Journalism, Life Sciences (e.g., Biology, Biochemistry, Molecular Biology), or a related field; equivalent professional experience will be considered.
• 2–3 years of technical writing experience within the life sciences, medical device, or in vitro diagnostics (IVD) industry.
• Excellent English, including speaking, writing, and editing skills.
• Strong understanding of regulated content development, including usability, risk communication, and labeling requirements.
• Hands-on experience with content management systems (CMS/CCMS), ideally in DITA/XML structured authoring environments.
• Proven ability to manage multiple documentation projects in a global, fast-paced, and regulated environment.
• Experience working with translations and simplified English.
• Experience with EU IVDR documentation requirements.

• Proven ability to create clear, compliant, and user-friendly content for laboratory technicians, clinicians, and regulatory reviewers.
• Multilingual skills (e.g., German, French, Spanish) to support localization and translation processes.
• Experience in use of reusable content strategies to drive consistency and efficiency.
• Strong cross-cultural communication and collaboration skills, with flexibility to work in a dynamic, global team setting.
• High attention to detail, accuracy, and a commitment to continuous improvement.
• Demonstrated technical curiosity and interest in understanding complex products and systems.
• Good collaborator with clear communication skills.
• Ability to work both independently and in collaboration with others, as well as the ability to handle both small and large tasks.
• Experience with EU MDR is an advantage.

Thermo Fisher Scientific