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Business Solutions Analyst (Regulatory Affairs)

Experis AG

Posted on Oct 29, 2021 by Experis AG

Zuchwil, Solothurn, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

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.

Tasks

  • 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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