Data Analyst Regulatory Affairs ( MDR)

Job content

• 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
• 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, but not required.
• Knowledge in project management
• Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745, MDR)

• 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 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
• Coordination of stakeholder management