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Petra Kaars-Wiele

Senior Director International Regulatory Affairs & Global Labeling at Abbott, Germany

Profile

Petra graduated from the University of Goettingen/ Germany with Diploma in 1980 and with Ph.D. in 1983. She joined Abbott Laboratories in the same year.

Petra has more than 34 years of experience in Regulatory Affairs and Quality Systems for Medical Device, currently responsible for all international regulatory matters, medical event reporting, risk management, managing translation for 26 languages and labeling activities at Abbott Diagnostics Division. She has experience in building Quality Management System according 9001 and 13485 and has passed a lead auditor training in 1997. Since then she has used that knowledge in training, setting up a QMS or consulting in that field internally and externally.