PRIMARY PURPOSE & ESSENTIAL JOB DUTIES:
The Device Documentation Control (DDC) Technical Writer is responsible for creating, maintaining, and controlling documentation for FDA-regulated and non-regulated software devices, including design documentation, technical specifications, release documentation, and user-facing materials. This role ensures documentation is accurate, current, compliant, and accessible throughout the product lifecycle, supporting both regulatory compliance and high-quality user experience.
The role’s essential job duties are as follows:
- Create, maintain, and manage controlled documentation for regulated and non-regulated software devices, including:
- Design and technical specifications
- User manuals and help documentation
- Release notes and labeling content.
- Ensure all device documentation and labeling comply with FDA regulations, internal Quality System requirements, and BBCS Standard Operating Procedures (SOPs), Standards (STDs), and Guidelines.
- Serve as a documentation partner within the Software Development Life Cycle (SDLC), actively participating in Agile ceremonies (refinement, sprint planning, reviews) and collaborating with cross-functional teams.
- Manage documentation updates through formal change control processes, ensuring alignment with product functionality, intended use, and approved releases.
- Utilize Jira to track documentation work, changes, and dependencies tied to development and quality activities.
- Maintain and publish documentation within Confluence, ensuring proper version control, review workflows, and accessibility for internal teams and external customers.
- Ensure labeling and documentation are available, current, and properly versioned in accordance with approved SOPs and regulatory expectations.
- Continuously improve documentation templates, workflows, and standards to support scalability, consistency, and usability.
OTHER JOB DUTIES:
As an employee within BBCS, this position will participate with the other staff members to contribute to and support the corporate goals, business plan, standard operating procedures and Corporate Quality Policy, and thus requires personal and professional integrity and work ethics.
QUALIFICATIONS AND EXPERIENCE:
Required
- Exceptional written communication skills with strong attention to detail
- Experience creating and maintaining structured technical documentation
- Proficiency with modern documentation and collaboration tools (e.g., Confluence, MS Word)
- Ability to manage multiple priorities in a fast-paced, Agile environment
Preferred
- Experience documenting software systems from both user and technical perspectives
- Familiarity with FDA-regulated environments (medical device, healthcare software, or SaaS)
- Experience with document control, change management, and quality systems
- Working knowledge of Jira for task and workflow tracking
- Experience leveraging AI-assisted authoring and review tools to streamline documentation creation and maintenance while maintaining regulatory compliance and document control standards
- Experience collaborating with Engineering, QA, Product, and Customer teams
EDUCATION
- BA/BS in Technical Writing, English, Communications or a related field, or equivalent professional experience.
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