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Regulatory Affairs Data / Business Analyst

Location: Zuchwil
Sektoren Pharma & Life Sciences
Anstellungsart Temporär
Gehalt Negotiable
Reference: 556918

Regulatory Affairs Data / Business Analyst

Experis IT Switzerland is in a search of a Regulatory Affairs Data / Business Analyst to join one of their clients, a well renowned finance company based in Zuchwil. It is a 12 months contract with high chances to get an extension. Due to business expansion, they are seeking a talented professional to join their existing team.

Linkedin: Martyna Slosarczyk

Start Date: ASAP
Duration: 12 months
Location: Zuchwil

Job Description:

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
  • Connecting with database/IT system owner to discuss system requirements updates
  • 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 and maintain global share point(s) for Regulatory Affairs
  • 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
  • Performing data analysis to ensure data integrity
  • Coordination of stakeholder management

The requirements:

  • Broad knowledge in database and data science incl. data management
  • Hands-on person: knowing how to work with tables, comparisons, macros
  • Strong analytical skills
  • Expert in MS office (focus on Excel, share point, power query)
  • Experience in IT system documentation
  • Understand the Medical device or Pharma environment e.g. MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745, MDR) and Council Directive 93/42/EEC (MDD)
  • Keen to understand the details of EUDAMED requirements or knowledge/understanding in databases
  • 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
  • Proficiency in English written and spoken. German in addition, not required.
  • Knowledge in project management

If you are interested, please send us your CV.

Linkedin: Martyna Slosarczyk

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