SaMD Technical Writer

Job Description

The role involves authoring and maintaining regulatory-compliant technical documentation for Software as a Medical Device (SaMD) products. You will collaborate with cross-functional engineering and regulatory teams to manage design controls and software release dependencies.

Requirements: Candidates need a degree in Systems or Software Engineering and over 5 years of technical writing experience, with at least 3 years in a regulated environment. Proficiency in medical device standards like ISO 13485 and IEC 62304 is essential.

Key Skills: Technical Writing, SaMD, ISO 13485, FDA 21 CFR Part 820, IEC 62304, ISO 14971, Software Architecture, Version Control, Cloud Infrastructure, CI/CD, Design Controls, Risk Assessment, Software Development Lifecycle, Change Management, Regulatory Compliance, UI Specifications

Benefits: Competitive Salary, Flexible And Supportive Work Environment, Professional Development Opportunities