The Client is a Major Medical Devices in Galway, Ireland
Senior Regulatory Affairs Specialist responsibilities encompass the support of worldwide product registrations and support of Regulatory activities.
Bachelor's degree level in Engineering, scientific, or technical discipline.
6+ years of Regulatory/Quality experience, 2+ years of medical device experience or relevant experience.
Dynamic team player and can work effectively and proactively on cross-functional teams. Experienced with U.S. and/or European/International regulations and standards
Experienced in preparing regulatory submissions; interacting with FDA and/or other regulatory agencies.
Provide a significant breadth of knowledge in Quality, project planning, technical expertise, and all areas of product development.
Have knowledge of FDA regulations and TÜV requirements.
Attractive Salary/Benefits on offer/negotiable
For immediate interview, please email your CV immediately to
For informal enquiries please phone Christy O'Hara on 087-9473404 or 00353 87 9473404 (if outside Ireland)