Newark, United States
11 months ago
- 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.