Sr. Regulatory Affairs Associate

GeneDx(10 days ago)

RemoteFull TimeSenior$110,000 - $120,000Regulatory Affairs

About this role

A Senior Regulatory Affairs Associate at GeneDx works within the company’s clinical genomics environment to support regulatory compliance for its IVD and SaMD offerings. The role is embedded in a multidisciplinary setting that interfaces with development, product, and laboratory teams to advance diagnostic products. This position is fully remote and aligned with GeneDx’s mission to deliver genomic-based diagnostic insights.

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Required Skills

ISO 13485
ISO 14971
ISO 15189
IEC 62304
EU IVDR
FDA Submissions
Design Controls
Risk Management
SaMD
Verification Validation

+2 more

Qualifications

Bachelor's or Advanced Degree (Biology, Chemistry, Engineering)
Regulatory Affairs Certification (RAC) - Preferred

About GeneDx

genedx.com

GeneDx is a clinical genomics company and diagnostic laboratory that helps clinicians and families find genetic answers through expert genome and exome sequencing. They provide comprehensive testing options — including whole exome and whole genome sequencing, targeted gene panels, and trio/parental analyses — paired with clinical interpretation by molecular geneticists. GeneDx supports providers and patients with detailed, clinically focused reports, genetic counseling resources, and variant classification informed by curated databases and clinical expertise. Clinicians rely on GeneDx for diagnosing rare and undiagnosed genetic conditions and for actionable genomic insights.

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