
Documentation Specialist
2 days ago
We are seeking a skilled technical writer to develop and maintain clear, accurate, and compliant documentation for immunodiagnostic products.
Key Responsibilities:
- Design and create high-quality technical content (IFU, DFU, labels, manuals, quick-start guides, digital aids).
- Translate complex scientific/regulatory information into clear, user-centric documentation.
- Evaluate compliance with regulatory requirements, including IVDD/IVDR, FDA 21 CFR Part 11, and ISO 13485.
- Collaborate with cross-functional teams to achieve project goals.
- 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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