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Technical Writer

2 months ago


Richmond, United States Premier Life Sciences LLC Full time

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.