Ireland
Quality Assurance and Regulatory Affairs Manager at Natus Medical
Medical Devices
Education
National University of Ireland, Galway 2015 — 2017
MSc in Regulatory Affairs Technology, Regulatory Affairs for Medical Devices
Institute of Technology, Sligo 2012 — 2014
Bachelor of Science (BSc), Quality Management and Technology
University of Limerick 1997 — 1998
Diploma, Quality Management, Second Class Honours Grade 1
Limerick Institute of Technology 1995 — 1997
City & Guildes Certificate, Quality Assurance, Credit
Limerick Institute of Technology 1987 — 1990
Engineering, Engineering
Saint Munchins College 1981 — 1987
Secondary School
Experience
Natus Medical July 2012 - Present
CareFusion Ireland August 2010 - Present
CareFusion May 2008 - August 2010
TE Connectivity April 1999 - May 2008
Snap On Tools January 1996 - April 1999
Snap On Tools October 1990 - December 1995
Skills
Sterility Assurance, Injection Molding, ISO 14971, Process Improvement, Regulatory Affairs, Iso 9000, Quality Management, Vendor Management, Statistics, Risk Management, Customer Service, Traceability, CE marking, Quality Assurance, Product Development, FDA GMP, Metal Fabrication, Six Sigma, Lean Manufacturing, CAPA, Regulatory Submissions, Validation, Quality System, Problem Solving, FDA, Quality Control, Auditing, Project Management, FMEA, Calibration, Management, Cross-functional Team..., Purchasing, Medical Devices, Medical Device Directive, 21 CFR, ISO 13485, KPI Reports, Continuous Improvement, Process Control, Design Control, Manufacturing