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
