Quality and Regulatory Affairs Project Manager
ARUP Laboratories
Chelsea Welch is a Quality and Regulatory Affairs Project Manager at ARUP Laboratories. She is responsible for regulatory strategy, compliance, and technical file preparation for companion diagnostics across multiple global markets. Chelsea has played a key role in submitting and obtaining regulatory approvals throughout the companion diagnostic product life cycle, including FDA Q-Submission, IDEs, PMAs, EU Performance Study Applications, and IVDR Technical Files.
Chelsea has 10 years of regulatory experience including companion diagnostics, clinical trials, and ethics committees.
Disclosure information not submitted.
Companion Diagnostics: Overview of the IVDR Requirements and the EMA Consultation Process
Thursday, October 5, 2023
4:45 PM – 5:45 PM EDT