Data / Business Analyst, Regulatory Affairs (m/w/x), Solothurn
View: 134
Update day: 20-03-2024
Location: Solothurn Solothurn SO
Category: R & D IT - Software
Industry: Information Technology Services Staffing Recruiting Retail
Position: Associate
Job type: Full-time
Job content
One of the our client is in need of Data / Business Analyst, Regulatory Affairs (m/w/x).For this reason, we are looking for a talented professional, who is willing to be a part of this project.General Information
Start date: asap
Duration: 31.12.2022
Extension: possible
Workload: 100%
Work location: Solothurn area
Remote: Mostly Onsite
Travel: no
Tasks & Responsibilities
- Support RA Business Lead 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
- 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
- Supporting hyper care phase
- 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.
- Proficiency in English written and spoken. German in addition, but not required.
- Preferably, basic experience in DePuy Synthes Trauma/CMF collaboration
- Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745)
- Basic understanding of requirements of current Council Directive 93/42/EEC
- Experience with previous Technical File remediation activities at Legacy Synthes: optional
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.
Deadline: 04-05-2024
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