Regulatory Affairs submission specialist
Posted on Mar 19, 2020 by Michael Bailey Associates - Zurich
Regulatory Affairs Data Analyst - contract 8 months
We have a new project available for an RA specialist with strong IT skills to support the Regulatory team to create an IT System for documentation and other 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 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.
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 at DePuy Synthes 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 and proficiency in English written and spoken.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.