Regulatory Affairs Data Analyst (Pharma and MDR)

ZuchwilTemporaryChemistry, Pharma, Biotech2019-04-11Master / University
For an international medical device company we are looking for a Regulatory Affairs Data Analyst with strong IT skills able to support the local franchise Regulatory team with the creation of an IT System documentation and other activities in conjunction with MDR compliance work.

Regulatory Affairs Data Analyst (Pharma and MDR)

Your challenges

•Support RA Business Lead in development and creation of IT System documentation for new functionality related to Technical Documentation requirements under MDR
•Perform User Acceptance Testing of newly implemented IT requirements as assigned
•Provide regulatory support for Life Cycle Management projects as assigned
•Manage data cleansing and comparison, remediation and maintenance of existing Technical File documentation as instructed and assigned
•Perform Regulatory Change assessments as assigned
•Perform Labeling and Promotional Material Reviews as assigned

Your skills

•Experience in IT system documentation and database management (Product Lifecycle Management (PLM)
•Understanding of MDR requirements regarding required content of Technical Documentation(focus on ANNEX II of Regulation (EU) 2017/745)
•Understanding of requirements of current Council Directive 93/42/EEC
•Previous experience in a Medical Device company preferred
•Comprehensive knowledge in the handling with and of data in PLM and ERP system, preferentially experience in Agile e6, ERP (SAP), Windchill
•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 would be an asset

Your contact

Are you interested in this job? Please apply directly online.

For any questions, please call us at +41 58 233 2102. Please mention reference in your call

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