SaMD Technical Writer

Artrya Ltd; San Francisco (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive Salary

Flexible And Supportive Work Enviro n.

Professional Development Opportunities

Job summary

Artrya Ltd is seeking a Regulatory Technical Writer to author and maintain regulatory-compliant documentation for SaMD products in a fast-paced environment.

You will collaborate with engineering and regulatory teams to ensure design controls are properly implemented and software release dependencies are managed effectively.

Qualifications

• Requires a degree in Systems or Software Engineering and 5+ years of technical writing experience.
• Minimum 3 years of experience in a regulated environment; knowledge of SaMD is preferred.
• Proficiency in medical device standards (ISO 13485, IEC 62304) is essential.

Responsibilities

• Author and maintain regulatory-compliant technical documentation for SaMD products.
• Collaborate with cross-functional engineering and regulatory teams to manage design controls.
• Oversee software release dependencies and regulatory traceability.

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

Education

Degree in Systems or Software Engineering

Tools

Git

CI/CD tooling

Cloud Infrastructure

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