Healthcare jobs
Research
Contract Design Control Scientist
Natera South San Francisco Posted Sep 30
About the role
This is a full-time, contract hybrid position in South San Francisco, CA. The Contract Design Control Scientist supports the Platform department by owning and improving design controlled documentation across the product development lifecycle.
What you'll do
- Author and maintain design controlled documentation in compliance with FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and GDPR.
- Translate laboratory processes, study plans, and analytical data into traceable, compliant deliverables (e.g., development reports, verification/validation protocols, specifications).
- Establish and maintain traceability across project documentation, linking requirements to design outputs and verification evidence.
- Review development reports, team resources, and software scripts to extract and synthesize information for controlled documents.
- Create onboarding and training documentation for R&D and CLIA team members, including training plans and departmental practice descriptions.
- Manage documentation filing, version control, and change-control workflows within quality management systems.
What you'll need
Natera lists the full requirements on its posting.