The Client is a Major Medical Devices in the Midlands, Ireland
Senior Regulatory Affairs Specialist responsibilities encompass the support of worldwide product registrations and support of Regulatory activities.
Bachelor's degree (or equivalent international degree) with 3-5 years of experience or equivalent combination of education and experience in supporting medical device manufacturing.
Proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications.
Possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD).
Have experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies.
Have strong writing, data analysis, and communication skills. The individual must have the ability to handle multiple demanding projects
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)