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Clinical Product Specialist

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. COVID-19 has demonstrated that we have reached the limits of healthcare capacity. Vitestro takes a first step towards addressing one of the most urgent societal problems with technology, increasing resilience of our healthcare systems.

Job description & responsibilities

We are now looking for a clinical product specialist, who will act as the bridge between our technical team and the hospital.
In this role you act at the forefront of Vitestro’s clinical product development. Your main task is to improve the device’s clinical performance, safety, and usability, in a heterogeneous patient population.
To achieve this, you help defining, organizing, executing, and analyzing clinical studies to test and optimize different product features.

For example, in one clinical test you could be focusing on patient positioning, whereas in another study you investigate how to improve technical device performance. You will work a lot with patients and hospital personnel, but also spend a lot of time on translating research findings into valuable technical input. In short, you take ownership of the clinical-technical challenges we encounter, which we will be key to the short and long-term success of the company.

Besides your core tasks, you will be asked to participate a part of your time on other tasks, such as product marketing, clinical and regulatory affairs, grant writing and/or business development. In a later, stage you will also focus on successful implementation of the device, closely working with clinical partners in this process. 

Job requirements

Must-have

Preferable

Our ideal candidate


Why choose for Vitestro?

The first 12 months, you focus on product development, for which clinical research with patients is essential. Since you become part of a fast-growing organization, thereafter you will get the opportunity to develop yourself in variety of other areas such as clinical & regulatory affairs and implementation. This provides lot of opportunities for personal development. We offer an annual personal development budget, 24 holidays, competitive salary including a pension plan, as well as stock appreciation rights (stock options) to become co-owner of the company.  
Most of all, we have a fun and highly skilled team which is great to work with!


Questions?

Please contact Luuk Giesen, medical officer at luuk.giesen@vitestro.com.

For recruitment agencies – no thank you.

Quality Assurance and Regulatory Affairs Officer (QA/RA Officer)

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 QA/RA officer

We now have a unique opportunity for a QA / 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. A couple of significant regulatory challenges are:

Your timing is perfect: you will be joining Vitestro during probably the most interesting QA/RA period in time as 2022 will be incredibly important. Vitestro will apply for an ISO 13485 certificate spring 2022 with its notified body. Additionally, Vitestro will explore its FDA strategy to prepare for its FDA submission.


Responsibilities

As QA/RA officer, you will be responsible for all the Regulatory Affairs and Quality Assurance within the company. This includes:

The QA/RA officer should keep the high-level overview of all the QA/RA processes within the company.

Several regulatory consultants are involved each with their own expertise (such as: clinical validation, biocompatibility) to help us crack the most difficult regulatory challenges.

You will report directly to the CEO of Vitestro and work closely together with our current QA/RA team & medical officer.

Job requirements

What is your must-have skillset?

Note: speaking Dutch is not required for this position.

What do we offer?

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.

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