Head of Global Registrations & Consultant
Since 2017, Daniëlle has been working for Qserve Group in various roles. She developed and implemented a new document management and communication platform in her role as Knowledge Management Specialist. In addition, Daniëlle has been overseeing the Global Registration Team. She has been collaborating with local partners to support Qserve clients with their medical device registrations in EMEA, LATAM and APAC countries.
Daniëlle about working at Qserve
"Working at Qserve means working in a very dynamic environment. Not only are legislations changing and thus challenging the industry, at Qserve we are always looking for a practical approach to serve our customers which means that not one day is the same. That is what I like about this job. Moreover, it is great to work with different people from different cultures, switching back and forth to talk with our local partners on a daily basis. It encourages you to stay focused and flexible."
Daniëlle has a Master's degree in Science, Business and Innovation with a specialization in Life & Health Sciences that emphasize on drug development, molecular diagnostics and innovative medical instrumentation.
She understands how science and business processes need to cooperate to succesfully introduce scientific knowledge and inventions into the market.
For her Bachelor thesis, Daniëlle conducted research at a medical device valorization company. She focused on the potential impact of the MDR on Research & Development of medical devices in SME companies. During her two-year Master's, she conducted a study in an new Gene Therapy Technology for Neurlogical Disorders and wrote her thesis on the Future of Clinical Data-Collection Pathways for Medical Devices under the MDR.
The key expertise areas of Daniëlle:
- Knowledge on registration requirements in EMEA, LATAM and APAC countries
- Support on medical device registration projects EMEA, LATAM and APAC countries
- Database registrations for medical devices
- Building up and maintaining partnerships with local partners in various countries
- Managing the European authorized representative customers
- Provide market access strategy reports
- Effective communication with Competent Authorities
Learn more about our services within Regulatory Affairs