Bachelor s Degree; Master s Degree 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

Bachelor s or master s degree in Computer Science, Technical Communication, English, Life Sciences, or a related Engineering field (eg, Biomedical)

5+ years of professional technical writing or software validation testing experience in a strictly regulated environment such as Medical Devices, IVD, or Biotechnology

At least 2+ years of experience in managing projects independently and owns end-to-end documentation life cycle in a regulated environment

Proven experience creating regulatory-compliant documentation (such as IFUs, User Manuals, or QRIs) that meets FDA, EU MDR/IVDR, and ISO 13485 standards

Strong experience in Adobe InDesign, Adobe Photoshop, Adobe Illustrator, and Camtasia for video creation

Mastery of professional authoring tools (eg, 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 new 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 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

As a Senior Technical Writer, you will develop, review, and publish regulatory-compliant technical documentation like IFUs and Service Manuals for GeneXpert systems, ensuring high-quality, localization-ready content for a global audience

This role requires 5+ years of experience in a strictly regulated environment (Medical Devices/IVD) and mastery of qualified authoring tools to collaborate effectively with clinical and engineering teams

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.

📌 Lead Technical Writer(Senior) (Bengaluru)
🏢 ItConnectUS
📍 Bengaluru