Beschreibung
For a Client in south Germany we are currently looking for a documentation specialist to review design historay files and write technical files for active medical devices of class III.The Documentation Specialist will be responsible for the maintenance and update of Technical Documentation Files to demonstrate conformity to essential requirements and essential principles of safety and performance, to ensure compliance to European and Global regulatory requirements.
Within the role you will update and maintain EU Full and Summary Technical Documentation (STED) Files, and MDD 93 / 42 / EEC, Annex I Essential Requirements Checklists. You will also update and maintain global technical files, and Essential Principles of Safety and Performance Checklists.
Working as an integral part of the Technical and Development team, this is a fantastic opportunity for an individual with some experience of working in the medical device industry, to enhance their career as a documentation specialist focusing on Technical Documentation Files, Essential Requirements & Essential Principles checklist's and Design History Files.
Therefore, individuals with a strong background in R&D of active devices and some experience of document control and an understanding of MDD 93 / 42 / EEC requirements, together with ISO 13485, FDA Design Control and 510k submissions, would be considered as ideal candidates for this position.
You may have experience of the following: Documentation Specialist, Medical Devices, ISO 13485, Technical File Specialist, Regulation, Documentation, Administration, MDD 93 / 42/ EEC, 510k, Documents Control Coordinator etc.
Moreover, German and English speaking and writing skills should be very good.
Please do not hesitate to contact me should you have any questions.
Ivan Seleme
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