Regulatory Affairs Associate

Adaptive Biotechnologies Corp.

. Assist with assembling regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and international markets .

Posted 9/30/2026full-timeRemote • United StatesJuniorMid-Level💰 $39 - $58 per hourWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory affairs for in vitro diagnostic devices, including knowledge of FDA guidelines and quality systems regulations. Capable of coordinating submissions and maintaining compliance with global health authority requirements.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Guidelines KnowledgeIVD Submission CoordinationQuality Systems Regulation (QSR) KnowledgeProcess Improvement Implementation

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory SubmissionsTechnical File DocumentationDocument Filing and RetrievalProcess ImprovementRegulatory Document ManagementProject Contract ReviewCompliance with SOPsAdverse Event ReportingMolecular Diagnostics KnowledgePCR-Based Assays Understanding

Certifications & Qualifications

Bachelor’s DegreeRegulatory Science Certification

Industry Keywords

In Vitro Diagnostic Devices (IVD)FDAGlobal Regulatory AgenciesCLIA LaboratoriesSequencing Technologies

About the role

Key responsibilities & impact

Assist with assembling regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in the US and international markets
Maintain FDA submission files and records, ex-US technical file documentation, and other regulatory documents and policies
Assist in writing and implementing process improvements for Regulatory Affairs functions
Maintain and perform regulatory document filing and retrieval in conjunction with SOPs
Compile, coordinate, and format materials required in submissions, license applications, and technical file documentation
Maintain files related to FDA/global regulatory registrations, including communications with FDA/global regulatory agencies
Coordinate and format submissions per FDA and other global health authority requirements
Assist in creating and implementing regulatory affairs policies and procedures
Review incoming project contracts and provide guidance on regulatory requirements
Inform cross-functional teams about new or revised standards, expanded claims, recalls, adverse events, and impacts on IVD products
Perform all other duties as assigned

Requirements

What you’ll need

Bachelor’s Degree
2+ years of experience in regulatory affairs in the diagnostic or pharmaceutical industry, regulatory science or related degree or certification, or other related experience
Knowledge and understanding of FDA guidelines with proven ability to successfully apply these to work output (preferred)
Knowledge of FDA and quality systems regulation (QSRs) (preferred)
Prior work with IVDs, molecular diagnostics, PCR-based assays, sequencing technologies and/or CLIA laboratories (preferred)
Not currently sponsoring candidates requiring work authorization support for this position

Benefits

Comp & perks

Equity grant
Bonus eligible
Remote work (WFH)