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Regulatory Affairs Specialist : Lab Diagnostics & FDA Submissions

Job in Dallas, Dallas County, Texas, 75215, USA
Listing for: Remote Jobs
Full Time position
Listed on 2026-09-01
Job specializations:
  • Healthcare
    Healthcare Compliance
Salary/Wage Range or Industry Benchmark: 65000 - 90000 USD Yearly USD 65000.00 90000.00 YEAR
Job Description & How to Apply Below
Position: Regulatory Affairs Specialist I: Lab Diagnostics & FDA Submissions

ARUP Laboratories in Salt Lake City, UT, seeks a Pharma Dx Regulatory Affairs Specialist I to support the development and submission of lab developed tests and companion diagnostics to the FDA and other global regulatory bodies for IVD approvals and clinical trials.

You will assist with IRB approvals, PDP-related processes, and ensure regulatory filings meet required standards while collaborating with cross-functional teams and sponsors.

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