Mieke Roelants is Director Regulatory Affairs and Market Access at genae and has a vast experience in Clinical Research. genae is the leading medical device Contract Research Organization (CRO), involved in the development and commercialization of investigational products and therapies that change medical practice.
She has broad experience in handling European regulatory requirements for clinical trials with medical devices, both in the pre- and post-market phase for small start-ups and large global medical device companies. In her role as Regulatory Affairs lead, Mieke is involved in numerous regulatory-related activities including Regulatory Submissions, Market Access and Reimbursement Strategies.
Mieke obtained a Master in Pharmaceutical Sciences at the KU Leuven and holds a PhD in Pharmaceutical Biology.
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Director Regulatory Affairs and Market Access, genae