
Senior Documentation Specialist
7 hours ago
Job Title: Technical Writer
We are seeking a skilled Technical Writer to develop and maintain clear, accurate and compliant documentation for immunodiagnostic products. This includes creating and editing high-quality technical content such as instructions for use, labels and manuals.
Key Responsibilities:
- Translate complex scientific and 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 cross-functional teams including product development, regulatory, QA and marketing.
- Contribute to continuous improvement of documentation standards and processes.
Qualifications:
- Experience in technical writing for life sciences and medical devices.
- Strong knowledge of regulatory documentation requirements.
- Excellent writing, editing and collaboration skills.
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