Regulatory Affairs Specialist

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with expertise in immunoassay, molecular testing, clinical chemistry and transfusion medicine. The Regulatory Affairs Specialist joins the Regulatory Operations group to assist with building and maintaining infrastructure and processes for the Clinical/Regulatory/Medical/Assay V&V department. This position is located in San Diego, CA.

Regulatory Operations provides infrastructure through creation and continuous improvement of regulatory processes, implementation of regulatory software systems, and management of centralized regulatory services. The specialist supports US State licenses, FDA registrations, EUDAMED registrations, and other domestic or international facility registration processes. Additional focus areas include external standards control and government database entries.

The role requires working cross-functionally to provide decisions on SAP system orders and update license information while integrating RA approvals into QMS documentation. Responsibilities also include organizing regulatory records in eDMS, routing draft documentation for review, and handling FURLS updates with annual renewals. Invoices within the RA operations group are managed directly.

QuidelOrtho prioritizes actions that support team member happiness, inspiration and engagement while building meaningful connections. Employees contribute to the mission of transforming the power of diagnostics into a healthier future for all through fast, accurate testing across more than 130 countries.