Regulatory Affairs Advisor
US$146,000 – US$182,500 / yr base salary
Posted 2 Oct 2026
BranchFactor Summary
The original posting with the fluff stripped out
- Expected experience
- 8+ yrs
- Management level
- People management
- Employment
- Remote
| Base salary | US$146,000 – US$182,500 / yr |
|---|
Field of studyLife Sciences (or related)
Study levelBachelor's
CertificationsMaster of Business Administration, Regulatory Affairs Certification (RAC)
Field of studyLife Sciences
Study levelMaster's or higher
POSITION SUMMARY
Title: Regulatory Advisor - FDA Pharma & IVDR
Natera is a clinical genetic testing company specializing in non-invasive, cell-free DNA (cfDNA) and liquid biopsy testing. The Regulatory Advisor plays a key role in developing and driving regulatory strategy on behalf of the regulatory affairs (RA) team, specifically focusing on FDA Pharma and IVDR initiatives. At Natera, we remember there is a person behind every sample. This role combines strong technical knowledge and an understanding of regulatory requirements (US FDA, CAP/CLIA/NYS, EU, or Japan) to support the approval and registration of products that proactively inform disease management.
You will represent the RA team to internal and external stakeholders through written and verbal communication. This role maintains product registrations, change assessments, post-market surveillance reports, and records of communication with regulatory authorities. You will support the overall effectiveness of the RA team through contributions to staff development, process improvements, and maintaining a deep understanding of current regulatory requirements in the evolving diagnostics landscape.
PRIMARY RESPONSIBILITIES
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Represent the regulatory function on designated cross-functional teams.
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Conduct business interactions with customers and regulatory authorities regarding regulatory pathways, performance claims, supporting data, and labeling in the context of submissions or registrations.
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Build and execute bold, practical regulatory strategies for complex regulatory affairs programs, with a heavy emphasis on FDA Pharma, IVDR, and In Vitro Diagnostic (IVD) systems.
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Advocate for the least burdensome approaches to product clearance and approval while strictly interpreting and adhering to regulatory requirements.
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Coordinate and prepare regulatory submissions with minimal supervision, including EU/IVD/IVDR Technical Documentation, classification requests, pre-submissions, 510(k) premarket notifications, investigational device exemptions, NYS DoH submissions, and critical worldwide registrations.
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Mentor regulatory associates and support their career advancement.
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Deliver training on regulatory topics across internal teams.
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Lead cross-functional teams to address major regulatory changes, compliance with new registration requirements, or process improvements.
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Contribute to setting individual and departmental annual goals aligned with business objectives.