Regulatory Affairs Specialist Job Overview
* We are seeking a highly skilled Regulatory professional to coordinate and manage all related RA activities for a designated list of countries as part of the EU regional team.
* This role will support and develop a regulatory submission plan for the region in terms of IVDR transition project in collaboration with Global RA IVDR project team, Legal manufacturing sites, supply chain, marketing, commercial, and in-country Distributors.
* The ideal candidate should have a Bachelor’s degree or equivalent, minimum 2 years' experience in Regulatory Affairs, preferably in Medical Devices, ideally in In Vitro Diagnostics, and excellent written and oral communication skills in English.
* Key responsibilities include supporting regulatory submission plans, managing change control projects, tracking regulatory milestones, representing RA at meetings, providing secondary support, and monitoring developing regulations.
* Responsibilities:
o Support regulatory submission plans
o Manage change control projects
o Track regulatory milestones
o Represent RA at meetings
o Provide secondary support
o Monitor developing regulations
Requirements:
* Bachelor’s degree or equivalent
* Minimum 2 years' experience in Regulatory Affairs
* Excellent written and oral communication skills in English
About This Role
This is an exciting opportunity for a highly motivated and experienced Regulatory professional to join our team. As a Regulatory Affairs Specialist, you will play a key role in ensuring compliance with regulatory requirements and driving business growth.