The Regulatory Specialist will support the Hematology, Urinalysis, and Flow Cytometry business units in meeting conformity to the EU In Vitro Diagnostic Regulation (IVDR). As a regulatory process expert supporting the IVDR teams, implements regulatory strategies for IVDR activities; Provides regulatory leadership in experimental designs, data analysis and product labeling as related to registration and commercialization of in vitro diagnostic devices; collaborates with the regulatory staff from other business units, companies, government agencies and Product Regulatory Subcommittees as needed to develop harmonized policies, procedures and work instructions for IVDR compliance.
https://www.indeed.com/viewjob?t=regulatory+affairs+specialist+ivdr&jk=ecb574eed39421f2&_ga=2.75632981.1335194151.1562012451-1429968906.1557248850
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