Technical Writer

4 weeks ago

Cochin, Kerala, India Vaisesika Full time

Job Title: Technical Writer – Immunodiagnostics

Location: Banglore-Hybrid

Role Overview:

We are seeking a skilled Technical Writer to develop and maintain clear, accurate, and compliant documentation for immunodiagnostic products, including IFUs, user manuals, product labels, and digital learning aids.

Key Responsibilities:

  • Create and edit high-quality technical content (IFU, DFU, labels, manuals, quick-start guides, digital aids).
  • Translate complex scientific/regulatory information into clear, user-centric documentation.
  • Ensure compliance with IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485, and internal quality standards.
  • Collaborate with Product Development, Regulatory, QA, Marketing, and Operations teams.
  • Contribute to continuous improvement of documentation standards and processes.

Qualifications:

  • Experience in technical writing for life sciences/medical devices.
  • Strong knowledge of regulatory documentation requirements.
  • Excellent writing, editing, and collaboration skills

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