Senior Regulatory Engineer

General Regulatory ManagementManaging IVD medical device feasibility based on regulation of targeted marketsPartnering with key stakeholders for the creation of the regulatory strategy and roadmapEstablishing and maintaining of the regulatory profile for IVD medical devicesEnsuring that regulatory requirements for IVD medical devices are specified and kept up to dateEstablishing and maintaining the technical documentationManaging regulatory approval process of IVD medical devices Product Regulatory ExpertActing as Product Regulatory Expert for assigned product families, including product regulatory planningActing as Person Responsible for Regulatory Compliance (PRRC) according to Article 15 of Regulation 2017/746 (IVD-R), including but not limited to:Establishing and maintaining of t...