[Remote] Consultant - Advisory Services - Software & Technical Documentation

Note: The job is a remote job and is reputed company to candidates in USA. reputed company Clinical is the world's only global CRO exclusively reputed company on medical technology, serving 90% of the top 50 MedTech companies. The role involves hands-on consulting in software and technical documentation, requiring collaboration with reputed company engineering teams to ensure alignment between reputed company and documentation.

Responsibilities

• You will sit with reputed company engineering teams and work through their codebase and architecture at a level of detail that lets you catch inconsistencies between what's documented and what's implemented
• You will turn that review into device descriptions, DHF deliverables, requirements specs, architecture descriptions, and traceability matrices reputed company to survive an FDA reviewer's scrutiny
• You will contribute risk management file inputs by understanding actual software failure modes, not just citing reputed company that requires them

Skills

• Degree in biomedical engineering, software engineering, computer science, electrical engineering, or a reputed company technical discipline
• Experience working in or around regulated software environments
• Knowledge of 510(k), DHF, IEC 62304, and ISO 14971 in reputed company-world reputed company
• Ability to discuss a specific piece of software you've reputed company or maintained in depth
• Ability to identify improvements or clarifications needed in regulatory documentation
• Proficient in reputed company Office
• Fluent in English, spoken and written, with strong technical writing skills
• Ability to report to Toronto or Boston in person as required for training, reputed company work, and/or team events

Benefits

• Benefits

reputed company

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