- Bachelor's or master's degree in Computer Science, Technical Communication, English, Life Sciences, or a related Engineering field (e.g., Biomedical).
- Ability to manage translation workflows for global markets and lead small projects, including training or mentoring colleagues to ensure high product quality and customer satisfaction.
- Working knowledge of key regulations, including FDA 21 CFR Part 820/Part 11, ISO 14971 (Risk Management), and GAMP 5, with the ability to maintain strict adherence to corporate style guides.
- Proven track record of integrating AI-driven workflows and Cloud capabilities to streamline the content lifecycle and enhance the delivery of global user documentation.
- 3-6 years of professional technical writing or software validation testing experience in a strictly regulated environment such as Medical Devices, IVD, or Biotechnology.
- Strong experience in Adobe InDesign, Adobe Photoshop, Adobe Illustrator, and Camtasia for video creation.
- Proven experience creating regulatory-compliant documentation (such as IFUs, User Manuals, or QRIs) that meets FDA, EU MDR/IVDR, and ISO 13485 standards.
- Mastery of professional authoring tools (e.g., Vasont, MadCap Flare, FrameMaker) and a strong working knowledge of document management and version control systems.




- Excellent interpersonal and writing skills, with the self-motivation to quickly learn recent molecular diagnostic technologies, such as PCR and clinical lab workflows.
- Perform duties as an individual contributor and team member with 100% hands-on work to develop, review, update, and publish regulatory-compliant documentation, including IFUs, Product Manuals, Getting Started Guides, and Service Manuals.
- Document product functionalities and manage documentation reviews to verify that technical information for Xpert tests and GeneXpert systems.
- Collaborate with Regulatory Affairs and Clinical teams to ensure documentation meets user needs and technical accuracy within a regulated environment.
- Create high-quality, localization-ready content designed for seamless adaptation across global regions.
- Build deep knowledge of company processes, molecular diagnostic technologies (like PCR), and customer needs to drive continuous quality improvements.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Technical Writer Professional (Bengaluru)
🏢 ItConnectUS
📍 Bengaluru