A Major Multinational Medical Devices Company in Galway, Ireland is seeking to recruit a suitably qualified person for the following post: Senior Regulatory Affairs Specialist.
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 an immediate interview, please email your CV immediately to
For informal enquiries please phone Sylvia Harrison on 087-8550555 or (00353)087-8550555 if outside Ireland