Regulatory Affairs system analyst - medical device

Switzerland  ‐ Vor Ort
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Beschreibung

Responsibilities:
* Support RA Business Department in development and creation of IT System documentation for new functionality related to Technical Documentation requirements, business improvements and further, requirements to be established under MDR
* Perform User Acceptance Testing of newly implemented IT requirements as assigned
* Create and support Software Life Cycle Development documentation
* Provide regulatory support for Life Cycle Management projects as assigned
* Create redlines on impacted business procedures based on the requirement changes from the IT projects
* Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned
* Coordination of stakeholder management
Requirements:
* Experience in IT system documentation and database management (Product Lifecycle Management (PLM)
* Knowledge in project management
* Expertise in MS office (focus on Excel)
* Experience in data science
* Experienced in Requirements Engineering and User Acceptance Testing
* Familiar with business process creation and creation of training materials
* Comprehensive knowledge in the handling with and of data in PLM and ERP system, preferentially experience in Agile e6, ERP (SAP), Windchill
* Experienced skills in MS Office (Excel, Word, Access) for data analyses and comparisons
* Strong analytical skills, knowledge of Share Point maintenance would be an asset.
* Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) )
* Basic understanding of requirements of current Council Directive 93/42/EEC

Michael Bailey International is acting as an Employment Business in relation to this vacancy.
Start
01/2022
Dauer
12 months
Von
Michael Bailey Associates
Eingestellt
28.10.2021
Projekt-ID:
2238535
Vertragsart
Freiberuflich
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