Regulatory Design Control Scientist (Contract)

Natera; South San Francisco (CA); Hybrid; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life Insurance

Fertility care benefits

401k with company match

Commuter benefits

Employee referral program

Job summary

Natera is seeking a Contract Design Control Scientist to join the Platform team in South San Francisco, CA. The role focuses on owning and improving design-controlled documentation across the product development lifecycle, bridging R&D science and regulatory compliance while delivering audit-ready deliverables.

The ideal candidate has a strong scientific background and proven ability to operate in regulated environments, collaborating with Engineering, Product Management, Data Science, and RA/QA

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.
• Experience in regulated environments 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 cross-functional collaboration with Engineering, Product Management, Data Science, Biostatistics, Science, 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 (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.

Skills

Regulatory knowledge

Medical writing

Cross-functional collaboration

Biotech background

Documentation and traceability

Education

BS or higher in a scientific discipline

Tools

MasterControl

Confluence

JSON/XML interpretation

Job description

Natera is seeking a Contract Design Control Scientist to join the Platform team in South San Francisco, CA. The role focuses on owning and improving design-controlled documentation across the product development lifecycle, bridging R&D science and regulatory compliance while delivering audit-ready deliverables.

The ideal candidate has a strong scientific background and proven ability to operate in regulated environments, collaborating with Engineering, Product Management, Data Science, and RA/QA