Technical Writer (ISO9000/ISO13485)

Job title: Technical Writer, Remote

Job summary:

We are seeking a dynamic and motivated individual to join our team as a Technical Writer (ISO9000/ISO13485)

Our team is currently seeking a technical writer who will be responsible for crafting comprehensive documentation. This pivotal role entails conducting research on technical matters, generating documentation for quality assurance purposes, and specifically entails crafting technical documents for applications, including those regulated by the FDA.

Responsibilities:

• Creating Solid Documentation: Developing clear, concise, and accurate documentation for software products, ensuring that it effectively communicates technical information to various audiences, including end-users, developers, and support teams.
• Documentation for Regulatory Compliance: Crafting documentation that adheres to regulatory requirements, such as those set by the FDA for medical software applications or ISO9000/ISO13485 standards for quality management systems in medical device manufacturing.
• Researching and Understanding Technical Concepts: Conducting in-depth research to understand complex technical concepts, processes, and functionalities, and translating them into easily understandable documentation for both technical and non-technical audiences.
• Collaboration with Subject Matter Experts (SMEs): Working closely with software developers, engineers, quality assurance professionals, regulatory affairs specialists, and other subject matter experts to gather necessary information and ensure accuracy and completeness of documentation.
• Maintaining Documentation Standards: Establishing and adhering to documentation standards, templates, and style guides to maintain consistency and quality across all documentation produced by the organization.
• Version Control and Document Management: Managing document versions effectively to ensure that the latest revisions are accessible to relevant stakeholders and maintaining an organized repository of documentation for easy retrieval.

Necessary

• 2+ Years experience on Technical writer position
• Fluent Technical English
• Solid knowledge in Technical documentation (User Manuals/Guides, System Requirements Documents, Software Design Specifications, API Documentation, Technical Whitepapers, Security Documentation, Compliance Documentation)
• Proficiency with API documentation
• Knowledge of Jira and a general understanding of Agile/Scrum principles

What we offer:

Trust-based management style and ownership culture.

Open, honest, reliable, and friendly team members.

100% Remote.

Flexible paid time off policy.

Competitive compensation based on your qualifications.