Beschreibung
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
Must Haves
- 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) )
- Basic understanding of requirements of current Council Directive 93/42/EEC
- Experience with previous Technical File remediation activities at Legacy Synthes: optional
If this outstanding opportunity sounds interesting for you, do not hesitate to contact me for more details or send me your CV.
Sthree Switzerland is acting as an Employment Business in relation to this vacancy.