Who we are
Vitestro will be the first to bring autonomous blood drawing technology to European hospitals. Blood drawing, performed billions of times per year worldwide, is key to clinical diagnosis. Given the mounting shortages of healthcare personnel and global population growth, there is a clear need for a future-proof system to guarantee continuity of care.
To help solve this problem we are developing an autonomous blood drawing device. We are the first in the world to develop a fully autonomous blood-drawing device using a combination of state-of-the-art A.I. and robotics. The venipuncture device uses infrared and ultrasound to localize the vein in the arm of the patient. A robotic positioning system controls the interaction between the ultrasound probe and the arm of the patient, while an ultrasound probe creates a 3D image of the vein using artificial intelligence (A.I.). The optimal insertion location is determined by the software algorithms to position the robotic needle insertion in the middle of the vein, ensuring accurate and secure blood collection. The procedure is performed fully automatically, from tourniquet to bandage application.
We are ambitious and strongly believe that we have only just started. Technology lies at our core: multidisciplinary team primarily consists of highly specialized hardware and software engineers. We also have our own medical team, driving clinical trials together with our clinical partners.
About the job
As a RA Officer at Vitestro you are responsible for you will be responsible for all the Regulatory Affairs within the company. With an emphasis on regulatory strategy and technical file documentation. Several regulatory consultants are involved, each with their own expertise (such as: clinical validation, biocompatibility) to help us crack the most difficult regulatory challenge. There are no comparable devices on the market; Vitestro will be the first company in the world to receive CE and in the future FDA approval on this device. Your timing is perfect: you will be joining Vitestro during probably the most interesting RA period in time as the next 12 months will be incredibly important. Additionally, Vitestro will explore its FDA strategy to prepare for a potential FDA submission. The system consists of a variety of subsystems and disposables, which each bring their own technical, clinical and regulatory challenges.
What we are looking for
What we offer
We need a go-getter who enjoys solving one of the toughest challenges. We are looking for someone who gets enthusiastic about reaching our goals as a team. A fit with our team values is important which are: Contribution to Patient care, Realizing breakthroughs, Team play, Ownership & Dedication, and Champions League (playing at the highest level).
For questions, please contact Mandla Malaba, email@example.com.
For recruitment agencies – no thank you.