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Fresenius Medical Care Deutschland GmbH


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Medical Device Compliance Expert Dialyzers and Filters (m/w/d) - limited for 1 year
Sankt Wendel
Aktualität: 01.06.2023


01.06.2023, Fresenius Medical Care
Sankt Wendel
Medical Device Compliance Expert Dialyzers and Filters (m/w/d) - limited for 1 year
Preparation and maintenance of the Technical Documentation / Regulatory documentation Management of technical documentation and STED requests from registration units Perform Regulatory activities to maintain/receive product compliance e. g. implementing (new) laws / regulations and changes Creation and preparation of declaration of conformity Support Regulatory Affairs and Value Streams projects from regulatory perspective, execution of change tasks Preparation of Instructions for Use Support and interface to Risk Manager Supporting function in case of Notified Bodies / Authorities audits for RA documentation review
University degree with an engineering, scientific or technical background Experience in Regulatory Affairs in a pharmaceutical or medical environment Advanced knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.) Advanced knowledge of applicable quality management and of risk management standards (e. g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR §820.250 etc.) Knowledge of sterilization processes, clean room requirements and of validation methods are advantageous IT user skills in MS Office (TrackWise Workflow or Windchill PDM systems are an advantage) Fluent in English (written and spoken) There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:



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