Regulatory Affairs Data / Business Analyst
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
