Snr. Reg. Affairs Specialist, Medical Devices,Offaly Ireland

  • Job Reference: NET 161734
  • Date Posted: 26 July 2018
  • Recruiter: Headhunt International
  • Location: Offaly
  • Salary: €80,000
  • Bonus/Benefits: Benefits Package
  • Sector: Engineering
  • Job Type: Permanent
  • Work Hours: Full Time

Job Description

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[1].

* 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