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. Backed by Lightspeed and Sequoia.
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. This role bridges R&D science and regulatory compliance; translating laboratory processes, study data, and software workflows into traceable, audit-ready deliverables. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- 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
- Strong scientific literacy with the ability to rapidly learn and document complex molecular biology and bioinformatics workflows
More about this 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. This role bridges R&D science and regulatory compliance; translating laboratory processes, study data, and software workflows into traceable, audit-ready deliverables. The ideal candidate combines a strong scientific foundation with the ability to navigate regulated environments, engage cross-functional stakeholders, and communicate complex technical concepts to audiences ranging from R&D scientists to clinical professionals.
- 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...
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