The Role:
PE Global is currently recruiting for a Senior Regulatory Affairs Specialist on behalf of a leading medical device company. This is an initial 12-month contract role.
Key Responsibilities:
* Coordinate and prepare document packages for regulatory submissions
* SUPPORT CHANGE CONTROL ACTIVITIES TO ENSURE GLOBAL APPROVAL AND IMPLEMENTATION OF PRODUCT AND PROCESS CHANGES
* Compile all materials required in submissions, license renewal, and annual registrations
* Collaborate with business unit Regulatory Affairs Specialists and international regulatory staff to provide regulatory support
* Develop robust regulatory strategies and resolve questions from regulatory agencies
* Recommend changes for labeling and internal documentation, reports for regulatory compliance
* Stay up-to-date with regulatory procedures and changes
* Support review of internal procedures to ensure continuous compliance with all regulatory requirements
* Maintain direct interaction with regulatory agencies on defined matters
* Support regulatory compliance activities, including manufacturing site registration & GMP audits as needed
* Identify and develop best practices within the Regulatory Affairs Department
Requirements:
* Bachelor's degree/master's in Science or Engineering (Honor's level)
* Minimum 5 years of relevant experience in Medical Devices, Pharmaceuticals, or Software regulated industries
* Regulatory experience in Class III devices and EU MDR
* Dynamic team player with strong technical knowledge
* Critical thinking and decision-making skills
* Experience with FDA regulatory requirements and international regulatory agency requirements
About Us:
Our client is a leading medical device company based in Galway.