Contract Design Control Scientist

Natera; South San Francisco (CA); Híbrido; USD 110.000 - 160.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical, Dental, Vision

Life Insurance

Fertility care benefits

401k with company match

Commuter benefits

Employee referral program

Descripción de la vacante

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

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Regulatory knowledge

Medical writing

Cross-functional collaboration

Biotech background

Documentation and traceability

Educación

BS or higher in a scientific discipline

Herramientas

MasterControl

Confluence

JSON/XML interpretation

Descripción del empleo

Position Summary

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.

Primary 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.

Knowledge, Skills, And Abilities

• Strong scientific literacy with the ability to rapidly learn and document complex molecular biology and bioinformatics workflows.


• Excellent written communication; clear, concise, and precise in producing regulated documentation.


• Strong attention to detail, particularly around traceability and regulatory language.


• Proficiency with quality management systems and document-control platforms (e.g., MasterControl) and collaboration tools (e.g., Confluence).


• Working knowledge of the product-development lifecycle and change-control management processes.


• Self-directed with the ability to manage multiple documentation deliverables independently.


• Preferred domain knowledge: LIMS, LIS, LES, and/or ELN; genomics data-analysis pipelines; laboratory instrumentation and software-compliance requirements.

OUR OPPORTUNITY

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women's health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives.

The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you'll work hard and grow quickly. Working alongside the elite of the industry, you'll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management.

What We Offer

Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program!

For more information, visit www.natera.com.

Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide.

Please be advised that Natera will reach out to candidates with a @natera.com email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes.

Link: https://www.natera.com/notice-of-data-collection-california-residents/

If you are based in California, we encourage you to read this important information for California residents.