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
SaMD Technical Writer in san francisco at Unknown Company
This position is listed as full time and onsite.