Regulatory Affairs Associate
| Preparation, coordination and compilation of regulatory documentation (technical files) for medical device and combination product dossiers for worldwide submissions, ensuring that regulatory requirements are met Continuous update of the dossiers according to new requirements received from authorities and deriving from technical changes Regulatory support for the development of medical devices and combination products to the technical departments as well as to QA functions and manufacturing departments Updating and maintenance of regulatory submission documents according to country specific requirements Close monitoring of regulatory requirements issued by the authorities and evaluation of their relevance for our dossiers |

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