Design Control Scientist - Regulated Documentation Pro

Natera, Inc.; South San Francisco (CA); Hybrid; USD 110,000 - 170,000; Full time

Job summary

Natera is a global leader in cfDNA testing, dedicated to oncology, women's health, and organ health. The Contract Design Control Scientist role in South San Francisco blends R&D science with regulatory compliance to produce audit-ready design-controlled documents across the product lifecycle.

Within the Platform department, you translate laboratory data and software workflows into traceable deliverables, drive change-control and collaborate with Engineering, Data Science, RA/QA to support a

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.
• Knowledge of FDA QMSR, 21 CFR Part 11, GCP, CAP/CLIA, HIPAA, IVDR, and/or GDPR.
• Experience interpreting JSON/XML for documentation purposes.
• Track record of cross-functional collaboration with Engineering, Product Management, Data Science, Biostatistics, Science, and RA/QA.

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.
• 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.

Skills

Scientific literacy

Written communication

Attention to detail

Cross-functional collaboration

Self-directed work

Education

Bachelor's degree in a scientific discipline

Tools

MasterControl

Confluence

JSON

XML

Job description

Natera is a global leader in cfDNA testing, dedicated to oncology, women's health, and organ health. The Contract Design Control Scientist role in South San Francisco blends R&D science with regulatory compliance to produce audit-ready design-controlled documents across the product lifecycle.

Within the Platform department, you translate laboratory data and software workflows into traceable deliverables, drive change-control and collaborate with Engineering, Data Science, RA/QA to support a