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:
Deal with safety challenges on needle insertion which should be single fault safe
Comply and adapt to the IEC 60601-1, which is not written for complex devices such as the one of Vitestro
Define a strategy for reprocessing
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.
As QA/RA officer, you will be responsible for all the Regulatory Affairs and Quality Assurance within the company. This includes:
Roll-out of QMS in the organization (SOPs have already been written)
Build-up of Technical File with our engineers
Communication with suppliers, competent authority, notified body, FDA, etc.
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.
What is your must-have skillset?
At least 5 years of experience in Quality Assurance and Regulatory Affairs, with focus on MedTech
Demonstrable achievements in bringing innovative MedTech products to the market and obtaining regulatory approvals (including CE and preferably FDA), strong knowledge of MDR
Ability to reason from first principles, based on a deep understanding of quality assurance and regulatory affairs, to support conformity of the whole system including all subsystems.
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 (IEC60601-1-2), software development (IEC 62304), clinical investigation (ISO 14155)
Knows how to setup a ISO13485 Quality Management System (QMS)
Excellent communication skills, in particular strong in regulatory writing and speaking in English
Project management skills including leadership 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:
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)
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, firstname.lastname@example.org