Regulatory Affairs Specialist II
This role involves supporting an exciting new project for the Infectious Disease Business Unit.
The successful candidate will coordinate and manage all related Regulatory Affairs activities for a designated list of countries as part of the EU Regional Team.
Key Responsibilities:
* Develop and implement regulatory submission plans for the region in terms of IVDR transition projects.
* Manage applicable change control projects for the regional team.
* Track regulatory milestones in internal databases using defined Key Performance Indicators.
* Represent Regulatory Affairs and/or the region at relevant meetings such as IVDR meetings or change control meetings.
* Provide secondary support as backup towards local Regulatory Affairs matters.
* Support strategic Quality and Regulatory Affairs goals and objectives.
* Maintain awareness of developing regulations and gather regulatory intelligence relevant to the business.
Requirements:
* Bachelor's degree or equivalent.
* A minimum of 2 years' experience in Regulatory Affairs, preferably in Medical Devices, ideally in In Vitro Diagnostics.