Regulatory Affairs Specialist - Medical Devices

Regulatory Affairs Data Analyst

We have a new project for a Regulatory Affairs Specialist to support the team with the creation of an IT System documentation and other activities in conjunction with MDR compliance work.

Your tasks:
Support RA Business Lead in development and creation of IT System documentation for new functionality related to Technical Documentation requirements under new medical devices regulations
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.

Requirements:
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
Experienced skills in MS Office (Excel, Word, Access) for data analyses and comparisons
Strong analytical skills and proficiency in English written and spoken.

This is 12 months contract based on site.

Michael Bailey International is acting as an Employment Business in relation to this vacancy.