Technical Writing Lead
- Idexcel
- 5 - 8 years
- Bengaluru
- 18 hours ago
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Job Description
Role & responsibilities
Mandatory Skills- Technical Writer / XML based authoring / IFUs / Dassault Inspire, Adobe InDesign, Illustrator , Photoshop , Frame maker (tool knowledge)
Lead Technical Writer(Senior).
5+ to 10 Years max.
Summary:
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. The role requires 5+ years of experience in a strictly regulated environment (Medical Devices/IVD) and mastery of professional authoring tools to collaborate effectively with clinical and engineering teams.
In this role, you will have the opportunity to:
- 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.
The essential requirements of the job include:
- Bachelors or masters degree in Computer Science, Technical Communication, English, Life Sciences, or a related Engineering field (e.g., 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 (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 new molecular diagnostic technologies, such as PCR and clinical lab workflows.
It would be a plus if you also possess previous experience in:
- 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.
Job Classification
Industry: Recruitment / StaffingFunctional Area / Department: IT & Information SecurityRole Category: IT & Information Security - OtherRole: IT & Information Security - OtherEmployement Type: Full timeContact Details:
Company: IdexcelLocation(s): Bengaluru
Keyskills: end-to-end documentation Medical Devices Regulatory Compliance ISO 13485 standards. Adobe InDesign Adobe Photoshop Adobe Illustrator Camtasia XML Technical Writing Dassault Inspire
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