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Technical Writer/Editor 2

  • Location

    Newark, United States

  • Sector:

    Business Professional

  • Job type:

    Contract

  • Contact:

    Sonu Chouhan

  • Job ref:

    21822

  • Published:

    11 months ago

  • Expiry date:

    2020-10-28

  • Create and finalize for in vitro diagnostic procedures, templates, checklists and files for compliance with European In Vitro Diagnostics Directive 98/79/EC (IVDD) and IVDR
  • Writes and edits technical documentation for products, processes and/or projects (user manuals, job aids, technical instructions/bulletins etc.).
  • Completes all phases of document development cycle, including scope and requirements, documentation design, etc.
  • Researches regulatory standards and guidance for information, and interviews with subject matter experts.
  • Support e-filing by reviewing and logging files to be uploaded into Documentum.
  • Education requirements: Bachelors of Art/Science
  • Regulatory Affairs Experience Preferred.