Head of Global Registrations
Qserve Group BV, Netherlands
Daniëlle leads Qserve's Global Registration team which supports MD and IVD manufacturers with market access and device registrations worldwide. Together with a team of consultants and regulatory affairs associates, they build market access strategies for manufacturers to enter different markets in an efficient and cost-effective way. Daniëlle is responsible for the local representative contracts in the different countries and communicates with the competent authorities as needed. The UK Responsible Person is the latest addition and with that also market access based on UKCA marking.
Additionally, Daniëlle takes on the role of interim RA/QA manager at legal manufacturers to ensure that technical files and the QMS are compliant. She has gained experience with a variety of devices from low to high risk and from small to large product portfolios over the past 5 years.
Daniëlle has a Master's degree in Science, Business and Innovation with a specialization in Life & Health Sciences that emphasizes drug development, molecular diagnostics and innovative medical technologies. She understands how science and business processes need to cooperate to successfully introduce scientific knowledge and inventions into the market.
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Career Development Session for Students
Tuesday, October 3, 2023
2:30 PM – 3:30 PM EDT
Tackling a Whirlwind of Uncertainties: Lessons Learned on UK Market Access
Thursday, October 5, 2023
2:00 PM – 3:00 PM EDT