Regulatory Affairs Associate
Introduction
Dennis joined Qserve in May 2022 as a Regulatory Affairs Associate as part of the Global Registrations team. He is located in the Arnhem (NL) office.
Dennis about working at Qserve
“From the first interview on, I experienced the dynamic, diverse, and honest environment within Qserve. I am eager to apply the acquired knowledge, learned during my studies and prior jobs at medical device companies, on daily basis at Qserve. Yet, I am also excited to immerse myself in the consultancy work’s new tasks and challenges to expand my regulatory and quality knowledge further.”
Before Qserve
Dennis had the opportunity to gain some regulatory affairs experience at various medical device companies next to his studies. His responsibilities varied from labeling-related projects, updating internal databases, and maintaining technical files to reviewing marketing materials. He learned how companies work with quality management systems ensuring that the processes are implemented.
Dennis obtained his Bachelor of Science degree in Industrial Design Engineering in 2016 and a Double Master of Science degree in Integrated Product Design (Medisign track) & Biomedical Engineering (Biomaterials & Biomechanics track) at the TU Delft in 2021.
During his master’s thesis, he developed a minimally invasive surgical instrument set for a revolutionary vertebral body augmentation system used to improve pain control and stabilize the spine in patients suffering from vertebral compression fractures. The core phases of the thesis were: scientific literature research into the spinal anatomy, competitor market research, interviews with orthopedic surgeons, physical concept prototyping, design verification with surgical instrument manufacturers, and validation tests with prototypes on synthetic & cadaveric specimens to validate mechanical & usability performance with quantitative and qualitative data.
The key expertise areas of Dennis:
- Support for global registrations in various countries
- Document review and registration of device manufacturers with the MHRA
- Standard gap analyses
- Thorough knowledge of ISO 13485
- Medical device (product) development
- Medical device usability testing
- Experienced in working with multi-disciplinary teams