Project Support Medical Device Regulation for irrigation solutions (m/f/d)

Project Support Medical Device Regulation for irrigation solutions (m/f/d) Employment with Hays Professional Solutions GmbH Bad Homburg Start date: asap Reference number: 514994/1 Diesen Job teilen oder drucken Your responsibilities MDR Remediation of design documentation for Irrigation Solutions (different combinations of 8 solutions and 8 containers) Gathering of exiting development documentation, currently not included in Technical File, from different client locationsDetailed review of documents with respect to availability and state-of-the-art, gap analysisSupport in development of a modular design documentation ? Harmonization of existing design documents (including risk analyses) and closing of identified gaps Your profile Experienced in Product Development of sterile single-use Medical Devices, preferably in the field of Irrigation SolutionsExperienced in Risk Management o Experienced in writing of design documentation, also in electronic systemsProfound knowledge of regulatory and normative requirements (MDR, ISO 13485:2016, ISO 14971:2019, IEC 62366)Good communication and team skills Your benefits Working in an international company