Eighteen years of experience in Quality Assurance and Regulatory Affairs of medicinal products., including combination products. Ten years of experience in medical devices and four years of experience in in vitro diagnostics. Working as a freelance regulatory affairs contractor/consultant over the past 15 years.
Lead Auditor/for candidate Notified Body, medical device and in vitro diagnostic expert.
Trained as Qualified Person, Responsible Person.
Go-to person in Quality Assurance and Regulatory Affairs of in vitro diagnostics, medical devices, medicinal products and enjoys working both in a team as independently.
Fluent in five languages (English, French, Italian, Maltese, Spanish) and basic German language skills, making it easy to communicate with people from different countries.