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Regulatory Affairs Specialist I
ARUP Laboratories. Support development and submission of lab developed tests and class III companion diagnostic medical devices to the FDA and global regulatory bodies .
Posted 10/15/2026full-timeSalt Lake City • Utah • United StatesJuniorMid-Level💰 $64,230 - $98,259 per yearWebsite
About the role
Key responsibilities & impact- Support development and submission of lab developed tests and class III companion diagnostic medical devices to the FDA and global regulatory bodies
- Support in vitro diagnostic approval processes and clinical trial activities
- Support IRB/ethics approval applications, continuing reviews, and decisional support
- Serve as regulatory affairs project support on product development teams
- Support implementation of Product Development Program, Design Control, and risk management practices
- Review Product Development Program documents for suitability in regulatory filings
- Prepare communications to product sponsors, the FDA, and other regulatory bodies
- Contribute to regulatory project requirements, timelines, deliverables, and compliance
- Assist with regulatory submission documents including IRB, SRD, IDE, PMA, performance evaluation applications, and non-US technical dossiers
- Support Design Control implementation and regulatory submission packages
- Author and review PharmaDx policies and procedures
- Assist with external audits by sponsors and regulatory authorities
- Support responses to supplier qualification questionnaires
- Participate in continuous improvement projects
- Support PharmaDx Quality and Regulatory Affairs management
- Support onboarding of new team members as needed
Requirements
What you’ll need- Bachelor's degree in Medical Laboratory Science, Biology, Chemistry, or equivalent degree
- Bachelor's Degree or better in Biological, Chemical, Scientific, or related field
- Two years of experience in pharmaceutical, IVD, or medical device industry working under design control
- 1–2 years of experience writing regulatory documents preferred
- Experience in Good Manufacturing Practice or Good Clinical Practice
- Intermediate to advanced experience with Microsoft Word, Excel, and PowerPoint
- One year of experience in regulatory affairs
- Working knowledge of ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, GCP, and other global standards
- Knowledge of Design Control, Product Development Program, and risk management
- Strong organizational, problem-solving, troubleshooting, and interpersonal skills
- Ability to use personal protective equipment in a biohazard laboratory environment
- Ability to comply with ARUP policies and procedures
Benefits
Comp & perks- Professional growth and continuous development
- Diversity-focused work environment
- Full-time schedule, Monday–Friday, 40 hours/week