Technical Writer/Editor 2
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Newark, DE 19702
Commercial Title: Technical Writer
- 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.
As a VEVRAA Federal Contractor, APN Software is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any other characteristic protected by law. APN complies with applicable state and local laws governing nondiscrimination in employment.