Quality Assurance & Regulatory Affairs Manager - Belgium

Quality Assurance & Regulatory Affairs Manager - Belgium

A super-hero working for the compliance of medical devices

💡 ISO 13485, 21 CFR, 510(k), MDR 2017/745, IVDR 2017/746 mean more than a series of numbers and letters for you?
💪 Working on several projects in parallel does not scare you? But, on the contrary, you are looking for a varied job?
🎯 Knowing that your job can have an impact on people's health gets you motivated to wake up every morning?

👉 Then you cannot miss this job ad!

COVARTIM is an engineering company. Our mission is to help the Med Tech industry foster medical innovation and improve health care.

More concrete we support any kind of organisation (practitioners, startups, SMEs, big companies) in the development and the certification of their medical technologies.

• Launched in 2016 by Kyun , Founder and Director,passionate about medical technologies and working in the field for more than 15 years;
• A (small) team of 15 people(24-52 years old) always readyto help each other (and play table football);
• 6 managers leading the team but also working on the projects:
  Aurore, Isabelle, Arnaud, Laurent, HervéandKyun;
• 40+ projects in parallel every month;
• 150+ clients in Be Ne Lux , France, USA, Japan, Finland, …

In order to answer the constantly growing demand from current and future clients, we are looking for additional members for our team Quality Assurance & Regulatory Affairs.

The job is located in Brussels or Liège for an open-ended period, to be filled immediately.

Ready?

🦸 Your mission will be to:

• Implement Quality Management Systems atour clients, based on the one we have developed;
• Perform internal and external audits at our clients;
• Develop regulatory strategies for the introduction of innovative medical devices on the market;
• Review and prepare documentation for Notified Bodies, FDA and the competent authorities;
• Provide our clients with operational support (hands-on);
• Perform regulatory watch andgap analysis to make sure we are still best-in-class.

We perform projects for our clients in our office in Brussels and in Liège. We go to our clients' premises for kick-off and follow-up meetings and for audits. Some clients want to see us once a week, others are located at thousands km from Brussels and only see us on Teams. This means that we spend most of our time at the office, together with the team.

Our members are gathered in two teams : the Development team and the Quality Assurance & Regulatory Affairs (QA/RA) team. As a QA/RA Manager, you will join the QA/RA team that includes 6 people and that is led by Aurore.

The mission of the QA/RA team is to help our clients achieve the compliance of their devices with regards to the regulatory framework and to provide support for the introduction on the market.

• Development of the US regulatory strategy for a software (Class IIa);
• Support to solve non-conformities after an audit on biocompatibility and packaging and to achieve CE mark for orthopaedic implant and instruments (Class III);
• Implementation of a QMS and support with the certification of a monitoring software (Class IIa);
• Support with the regulatory analysis, QMS implementation and certification (Class
  
  C).

• Good understanding of Medical Devices and IVD regulatory environment (directives, regulations);
• Good knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards;
• Speak French/Dutch and English to communicate with our clients and our cosmopolitanteam;
• Make clients' satisfaction a priority by combining quality and professionalism;
• Driving license

We are looking for people with a proven experience in order to make our clients and colleagues benefit from an advanced expertise. You will get introduced to our methods then you will take the full lead on challenging projects.

Once a year you will define your goals with your manager. It will be a good opportunity to discuss your expectations and needs in terms of responsabilities and training as well as your…