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.

Requirements:

• 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.)