Full-Stack Developer Needed – Build Regulated Requirements/Test/Compliance Management System
Budget: $3,000 – $5,000 USD
We are looking for an experienced full-stack developer (or backend-focused developer) to help us build a unified Regulated Software Lifecycle Management System that combines features of:
• Jama Connect (Requirements Management)
• Ketryx (Compliance & Risk Management)
• TestRail (Test Case Management)
The goal is to create a modular platform that supports requirement traceability, test planning, risk scoring, and regulatory compliance (21 CFR Part 11, ISO 14971).
⸻
Key Responsibilities:
• Design and implement RESTful APIs (Node.js or Python preferred)
• Build modules for:
• Requirements authoring & versioning
• Test case management and result tracking
• Risk scoring and control mapping
• Set up RBAC (Role-Based Access Control)
• Implement immutable audit logs and signature verification
• Integrate with external tools (Jira, GitHub) via API
• Collaborate via GitHub, Slack, and milestone reviews
⸻
Required Skills:
• Proficient in Node.js + Express or Python + FastAPI/Django
• Experience with PostgreSQL, JWT, and OAuth2
• Strong understanding of audit logging, versioning, and API security
• Familiarity with regulated environments (e.g. ISO 13485, ISO 14971, 21 CFR Part 11)
• Git, Docker, REST APIs, Swagger/OpenAPI
⸻
Bonus Skills (Preferred):
• Experience with Jama, TestRail, Ketryx, or similar tools
• React.js frontend experience
• Prior work with air-gapped or on-premise deployments
• Knowledge of FedRAMP, HIPAA, or FDA compliance requirements
• Jama Connect (Requirements Management)
• Ketryx (Compliance & Risk Management)
• TestRail (Test Case Management)
The goal is to create a modular platform that supports requirement traceability, test planning, risk scoring, and regulatory compliance (21 CFR Part 11, ISO 14971).
⸻
Key Responsibilities:
• Design and implement RESTful APIs (Node.js or Python preferred)
• Build modules for:
• Requirements authoring & versioning
• Test case management and result tracking
• Risk scoring and control mapping
• Set up RBAC (Role-Based Access Control)
• Implement immutable audit logs and signature verification
• Integrate with external tools (Jira, GitHub) via API
• Collaborate via GitHub, Slack, and milestone reviews
⸻
Required Skills:
• Proficient in Node.js + Express or Python + FastAPI/Django
• Experience with PostgreSQL, JWT, and OAuth2
• Strong understanding of audit logging, versioning, and API security
• Familiarity with regulated environments (e.g. ISO 13485, ISO 14971, 21 CFR Part 11)
• Git, Docker, REST APIs, Swagger/OpenAPI
⸻
Bonus Skills (Preferred):
• Experience with Jama, TestRail, Ketryx, or similar tools
• React.js frontend experience
• Prior work with air-gapped or on-premise deployments
• Knowledge of FedRAMP, HIPAA, or FDA compliance requirements