
Documentation Specialist
5 hours ago
We are seeking a skilled professional to develop and maintain high-quality documentation for immunodiagnostic products.
Key Responsibilities:- Create clear, accurate, and compliant technical content (IFUs, user manuals, product labels, and digital learning aids).
- Translate complex scientific/regulatory information into user-centric documentation.
- Ensure compliance with IVDD/IVDR, FDA 21 CFR Part 11, ISO 13485, and quality standards.
- Collaborate with Product Development, Regulatory, QA, Marketing, and Operations teams.
- Contribute to continuous improvement of documentation standards and processes.
- Experience in technical writing for life sciences/medical devices.
- Strong knowledge of regulatory documentation requirements.
- Excellent writing, editing, and collaboration skills.
The ideal candidate will have experience working in the life sciences industry and a strong understanding of regulatory documentation requirements. Strong writing, editing, and collaboration skills are essential for this role.
As a professional in this field, you will play a critical role in developing and maintaining high-quality documentation for our products. If you are a detail-oriented writer with excellent communication skills and a passion for creating engaging content, we encourage you to apply.
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