Caroline Soulet

With 19 years of experience in Regulatory Affairs, I joined the Nexialist team in May 2021.

I have worked for different medicines and medical device companies. These experiences have allowed me to combine operations and strategy and to evolve in an international environment. I was able to set up Regulatory Affairs departments and get involved in all activities relating to regulatory obligations (constitution of European and international technical documentation), combined with reimbursement, compliance and quality activities. I then accompanied medical device companies for nearly 3 years in the CE marking procedure by establishing an appropriate regulatory strategy as well as in the constitution and update of the technical documentation including in particular the drafting of the clinical evaluation. as an freelance consultant.

Within Nexialist, I am responsible for the compliance of technical documentation and regulatory strategies with the aim of sharing my expertise with my colleagues and our clients.