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Waiss Faissal
Quality, Regulatory & Compliance Manager for Northern Europe at Ortho Clinical Diagnostics

Profile

Waïss Faissal works in Ortho Clinical Diagnostics as Northern Europe & DACH Quality, Regulatory and Compliance Manager. He is responsible for the Regional Quality, Regulatory and Compliance activities in UK, Nordics, Benelux and DACH. His responsibilities include among others, the conformity of the company’s regulatory and quality processes to local and international regulations, the support to commercial processes, support for external audit program, for the Health Care Compliance and Environment Health Safety activities. 

Waïss brings a rich experience in different medical device & IVD regulatory roles which was kick started as Regulatory Affairs and Clinical Studies Manager in Switzerland. He then moved to Washington D.C. where he was Certification Project Manager for GMED as he supported companies in the CE-marking process and QMS requirements under MDSAP (Medical Device Single Audit Program). 

More recently, Waïss was based in Paris as Sr Regulatory Scientist on Medical Devices, Combination products and IVDs where he was in charge of regulatory and quality system strategies (CE-mark, 510k). In his different roles he was also appointed as ISO 9001:2015 and ISO 13485:2016 auditor. 

Waïss holds a Pharmacy degree from the Université Paris Saclay and a Biomedical Engineering Master degree from Ecole Nationale Supérieure des Arts et Métiers (France). He speaks fluent French, Faarsi and English and has an intermediate level in German. 

 

Agenda Sessions

  • Creating and Maintaining a Robust QMS System

    14:25