Diagnostic Regulatory Affairs IH / Operations Specialist

Sobre este empleo

Mission We are looking for an Immunohematology (IH) / Operations Regulatory Affairs Specialist to join Diagnostic Regulatory Affairs department. The RRAA Specialist will be responsible for the preparation of technical documentation, submission, following up and controlling of product registration and/or renewal, variations dossiers, as well as giving support to Regulatory transversal project. What your responsibilities will be Prepare and send the registration and/or renewal and/or changes/variations dossiers of the relevant products. Prepare technical documentation based on the R&D inputs. Coordinate the preparation of the documents needed for regulatory submissions with R&D, manufacturing and QA departments.…

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