Senior Technical Writer (Medical/Software)
Core
Lead authoring and maintenance of software lifecycle documentation for medical device software in regulated healthcare environments, ensuring compliance with FDA and international standards.
Role type
Senior Technical Writer (Medical Device Software)
Builds
Audit-ready documentation for medical device software development lifecycle
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
IEC 62304, ISO 13485, ISO 14971, FDA design controls, software requirements management, traceability matrices, verification and validation documentation, QMS/eQMS processes, Jama, Polarion ALM, DOORS, JIRA
Preferred skills
21 CFR Part 820, Git-based version control, connected devices documentation, Agile environments, user-facing labeling validation
Technologies
Jama, Polarion ALM, DOORS, JIRA
Responsibilities
Lead authoring and maintenance of software lifecycle documentation in compliance with IEC 62304, ISO 13485, ISO 14971, and FDA regulations; Own and maintain software requirements, architecture and design descriptions, verification and validation documentation, and traceability matrices; Translate software intended use, system behavior, and risk controls into clear, regulator‑ready documentation; Support design control activities including design inputs, outputs, verification, validation, and change management; Collaborate closely with Software Engineering and QA teams to ensure documentation accurately reflects implemented functionality and test evidence; Support internal and external audits, inspections, and regulatory submissions with audit‑ready documentation
Seniority
Senior, hands-on IC
