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Contract Design Control Scientist

Natera· Platform
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Hybrid (South San Francisco, CA)contractPosted 2w ago

About the role

Full-time, contract hybrid role in South San Francisco, CA focused on owning and improving design controlled documentation across the product development lifecycle, bridging R&D science and regulatory compliance to produce audit-ready deliverables.

Responsibilities

  • 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.
  • Identify opportunities to improve documentation processes, templates, and deliverable quality.
  • Perform other duties as assigned.

Qualifications

  • BS or higher in a scientific discipline (molecular biology, biochemistry, genomics, or related field) or equivalent industry experience.
  • 5+ years of experience producing controlled documentation in the medical device, IVD, or life science industry.
  • Demonstrated experience working in a regulated environment with knowledge of FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and/or GDPR.
  • Experience interpreting software implementations and structured data formats (JSON, XML) for documentation purposes.
  • Track record of working cross-functionally with Engineering, Product Management, Data Science, Biostatistics, Science, and RA/QA teams.

Skills

Required:Design control documentation
Last updated Oct 8, 2026. Interested? Apply on the company site.

About Natera

A global leader in cfDNA testing

Dedicated to oncology, women’s health, and organ health. Natera’s cell-free DNA tests help protect health and inform more personalized decisions about care.

oncologywomen's healthorgan healthcell-free DNA
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