For our client a franchise of orthopaedic and neurosurgery companies, located in Zuchwil, we are looking for a new team member as a
Data / Business Analyst, Regulatory Affairs
In this position you will support local franchise Regulatory team for various activities in conjunction with MDR compliance work.
* 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
* University/Bachelors Degree or Equivalent
Start Date: 01.12.2021
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Judith Atgé Martin (+41 61 270 80 16).