Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of our families, our communities and the world. We are a leading manufacturer of point of care diagnostic solutions. Quidel’s comprehensive product portfolio includes tests for a wide range of infectious diseases, cardiac and autoimmune biomarkers, as well as a host of products to detect COVID-19. Quidel pioneered the first FDA-cleared point-of-care test for influenza in 1999 and was the first to market a rapid SARS-CoV-2 antigen test in the U.S.
We are looking for a remote Regulatory Affairs Manager to join our Regulatory Affairs team. The Regulatory Affairs Manager implements regulatory activities related to the approval of new IVDs (in vitro diagnostics) and medical devices into the worldwide market, as directed. Participates on product development teams and provides guidance and strategies for regulatory issues. Interacts with regulatory agencies regarding product registrations, licensures and permits, and supports regulatory compliance to QSR, ISO, CMDR, MDSAP, IVDD/IVDR, CFR and other worldwide regulatory requirements. Reviews and approves labeling and Marketing/Sales literature.