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Vanessa Bonomi
More than 15 years of experience in regulatory and quality area of pharmaceutical, medical device and in vitro diagnostics medical device industries. Senior management experience in the regulatory compliance in the EU and in the global market authorizations in the Americas and Asia-Pacific, leading the MDSAP certification and dealing with the main Regulatory Authorities. Expertise in the quality assurance system and in the regulatory aspects of design controls, risk management, complaint and post-market surveillance. Strong skills in regulatory strategy acquired with the participation to international projects of product development and supporting manufacturing transfer. Focused on the key quality and regulatory affairs initiatives to drive continuous improvement and to be a bridge builder between the regulatory requirements and practical implementation in companies.