Manager, Regulatory Operations and Compliance - Global Submission Management
Since December 2013
Site Lead Publishing Team in Braine Alliance Park & Life Science Park Malta (Medical Products, EMEA and Emerging Markets). Global Submission Management.
Regulatory Affairs Manager
January 2012 --- December 2013
Responsible for Regulatory Affairs, Quality Management System and Pharmacovigilance in the Belgian Affiliate.
Senior Associate Regulatory Affairs & Compliance
August 2009 --- September 2011
Mainly involved in Clinical Studies, Registration and Healthcare Compliance.
Regulatory Affairs Operations Associate
October 2006 --- August 2009
Creation of electronic and paper RA submissions in EU (National, MRP, PSUR, ...).
Safety Operations Specialist
April 2005 --- October 2005
Post-marketing surveillance for Medical Devices in EU.
October 2000 --- April 2005
in bio-engineering from Vrije Universiteit Brussel in 2000
in Maths (8h) - Science from Koninklijk Atheneum Koekelberg in 1994