Vacancy expired!
Position: Technical Writer (Experience with FDA regulatory compliance) Location: Santa Clara CA (Initial Remote) - Local to CA Duration: 6 months. Required:
- Support development processes and tool integration
- Identify and escalate potential document generation improvements
- Identify process gaps and potential inefficiencies, articulate and recommend potential improvements.
- Describe, in translatable English, complex processes.
- Work with multi-disciplinary project team members to produce and maintain world-class project
- Documentation deliverables (DHF) through providing hands-on examples.
- Write for a variety of audiences, from non-technical end users to software engineers and regulatory
- bodies (such as FDA).
- Monitor metrics on the quality of the produced documentation as well as identifying and implementing
- improvements to the documentation process.
- Seek to refine process descriptions, to arrive at succinct, concise descriptions - avoiding
- verbose and dense demonstrations of pedantic prose.
- Strong understanding of Quality Management Systems (QMS) and regulations (IVDR, 21CFR820)
- Strong understanding of Standalone Software, especially in regards to regulations, design,
- Development, and auditable artifacts.
- Associate's Degree, or equivalent combination of education and work experience
- 3+ years of technical writing experience.
- Strong written and verbal communications and experience working with content in multiple mediums.
- Experience working with the following tools preferred: Confluence/JIRA, Git/Github, Microsoft
- Office suite, Google Docs/Spreadsheet/Slides, IntelliJ.
- Knowledge of relevant international ISO Standards (ISO 13485, 14971, 62304)
- 3+ years of experience within a Regulated Industry (medical device / pharma preferred.)
Vacancy expired!