PharmaDx Regulatory Affairs Specialist I

ARUP Laboratories•Salt Lake City, UT

6d•Onsite

About The Position

The PharmaDx Regulatory Affairs Specialist I supports the development and submission of lab developed tests and companion diagnostics (class III medical devices) to the FDA and other global regulatory bodies for in vitro diagnostic (IVD) approval and/or performance of clinical trials. The PharmaDx Regulatory Affairs Specialist I supports IRB/ethics approval applications, continuing reviews, and decisional support. The Specialist I has knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP) and risk management. The Specialist I serves as regulatory affairs project support on product development teams, assists in supporting the proper implementation of PDP practices by project teams, and reviews PDP documents to ensure their suitability for regulatory filings. The Specialist I is also responsible for supporting preparation of communications to product sponsors and the FDA or other regulatory bodies, as needed. The Specialist I reports to PharmaDx Quality and Regulatory Affairs management.

Requirements

Knowledge of Design Control and/or PharmaDx’s Product Development Program (PDP) and risk management.
Working knowledge of applicable regulations and standards (e.g. ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, GCP, and other global standards).
Working knowledge of Good Documentation Practices and design change control.

Responsibilities

Uses working knowledge of applicable regulations and standards (e.g. ISO, FDA, IVDD/IVDR, CAP/CLIA, GMP, GCP, and other global standards) to contribute to project teams that develop and seek approval for companion diagnostic tests and to support clinical trials.
Supports the regulatory aspects of PharmaDx projects in order to meet requirements, timelines, and deliverables and to maintain compliance with applicable standards, regulations, and policies.
Assists in the preparation of regulatory submission documents for the FDA or other regulatory agencies (e.g., IRB, SRD, IDE, PMA, performance evaluation application, non-US technical dossier).
Works closely with project teams to implement Design Control, risk management, or other applicable principles, and supports associated regulatory submission processes, documents, and submission timelines.
Provides assistance to the project team for implementation of ARUP’s Design Control program as it relates to supporting a responsive and compliant regulatory submission package.
Possesses a working knowledge of Good Documentation Practices and design change control.
Supports authoring and review of PharmaDx policies and procedures to ensure compliance with FDA and other regulatory agencies.
May assist in supporting external audits by sponsors and regulatory authorities.
Supports regulatory-related responses on supplier qualification questionnaires.
Participates in continuous improvement projects.
Supports PharmaDx Quality and Regulatory Affairs management, as needed.
May support onboarding of new team members.
Other duties as assigned.