Introduction

Vitestro is working on an autonomous blood drawing device with a team of >30 people. This breakthrough innovation, which is in a clinical stage of development, uses a combination of state-of-the-art imaging and robotics to perform an invasive clinical procedure. With this device, Vitestro can support healthcare staff in their daily clinical work, increasing access to care for patients.

We are ambitious, and strongly believe that we have only just started. Technology lies at our core: our 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.

Our new RA officer
We now have a unique opportunity for a RA officer to join our team. 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. The venipuncture device is the first medical device on the market that makes an autonomous a decision based on images to insert a needle in a human body.
The system consists of a variety of subsystems and disposables, which each bring their own technical, clinical and regulatory challenges.

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.

Responsibilities

As RA officer, you will be responsible for all the Regulatory Affairs within the company. This includes:

• Regulatory strategy

• 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 challenges.

What is your must-have skillset?

• 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

• 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)

• Excellent communication skills, in particular strong in regulatory writing

• Familiar with ISO 13485 Quality Management System (QMS) and MDSAP

• Project management skills

• Bachelor’s degree or higher, preferably technical background

• Affinity with technology

• Strong analytical skills, eye for detail

Note: speaking Dutch is not required for this position.

What do we offer?

• Competitive salary including pension plan

• Stock option package, to become co-owner

• An inspiring working environment:

• o Work with driven and talented colleagues, that love to realize breakthroughs

• o Experience an open culture, where direct feedback is strongly encouraged

• o Focus on team play, including frequent out-of-work activities (such as ski-trips)

What do you need to know before applying?

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 Luuk Giesen, luuk.giesen@vitestro.com.

For recruitment agencies – no thank you.