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

• At least 5 years of experience in Regulatory Affairs for medical devices
• Demonstrable achievements in bringing innovative MedTech products to the market and obtaining regulatory approvals (including CE and preferably FDA), strong knowledge of MDR
• Excellent communication skills, in particular strong in regulatory writing (Dutch is not a requirement)
• Strong analytical skills, eye for detail
• Experience with and knowledgeable in a multitude of widely used standards such as risk management (ISO 14971), usability (IEC 62366), biocompatibility (ISO 10993), basic safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software development (IEC 62304)
• Familiar with ISO 13485 Quality Management System (QMS) and MDSAP
• Project management skills
• Bachelor’s degree or higher, preferably technical background
• Affinity with technology

What we offer

• Competitive salary including pension plan
• Stock option package, to become co-owner
• An inspiring working environment
• Work with driven and talented colleagues, that love to realize breakthroughs

• Experience an open culture, where direct feedback is strongly encouraged
• Focus on team play, including frequent out-of-work activities (such as ski-trips)
• Daily lunches in the office

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, mandla.malaba@vitestro.com.

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