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Business Solutions Analyst (Regulatory Affairs)

Experis AG

Posted on Oct 29, 2021 by Experis AG

Zuchwil, Solothurn, Switzerland
Immediate Start
Annual Salary

Business Solutions Analyst (Regulatory Affairs)

Our Pharmaceutical client in Zuchwil, Solothurn is looking for a motivated team member to support a 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

Must have:

  • 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.
  • 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

Language skills:

  • Proficiency in English written and spoken. German in addition, but not required.

General Information:

  • Start date: ASAP
  • End date: 12 Months
  • Workload: 100%
  • Work Location: Zuchwil

For further information, please contact your Experis Recruiter, Elaine Kanwar or apply directly online.

Reference: 1381981563

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