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Technical Writer
2 months ago
Job Title: Medical Device Technical Writer (DHF Tech File Remediation)
Location: Virginia - Onsite
Duration: 6+ months (Contract)
**No C2C**
Job Description:
We are seeking an experienced Medical Device Technical Writer to support a Design History File (DHF) Technical File remediation project. The ideal candidate will have a strong scientific background, experience with both paper and electronic documentation systems, and a deep understanding of In Vitro Diagnostic Regulation (IVDR).
Key Responsibilities:
- Review and remediate DHF and Technical Files in compliance with IVDR standards.
- Manage both paper-based and electronic documentation to ensure regulatory compliance.
- Work closely with cross-functional teams to gather, verify, and organize scientific data for documentation.
- Create, edit, and maintain high-quality technical documents to support regulatory submissions.
- Ensure that all documentation meets internal and external quality standards.
Must-Have Skills:
- Extensive knowledge of IVDR (In Vitro Diagnostic Regulation).
- Experience with paper and electronic-based documentation systems.
- Strong scientific background to accurately interpret and document technical information.