Quality Assurance & Regulatory Affairs Manager
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!
Who we are?
COVARTIM is an engineering company. Our mission is to help the MedTech 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.
In a nutshell:
- 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 ready to help each other (and play table football);
- 6 managers leading the team but also working on the projects: Aurore, Isabelle, Arnaud, Laurent, Hervé and Kyun;
- 40+ projects in parallel every month;
- 150+ clients in BeNeLux, 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 ?
Practically, what will you do?
🦸 Your mission will be to:
- Implement Quality Management Systems at our 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 and gap analysis to make sure we are still best-in-class.
How ?
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.
What about 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.
Examples of projects:
⭐ 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).
In order to fulfill your mission, you will need:
- 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 cosmopolitan team;
- Make clients' satisfaction a priority by combining quality and professionalism;
- Driving license
Required seniority level
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.
Our offer
Salary range and other benefits:
Based on your skills and seniority, you can expect a monthly gross salary within 2.800 euros and 5.500 euros.
In addition you will get meal vouchers (8 euros/day), a supplemental health insurance (DKV Belgium) and a complementary pension.
Public transport costs are fully covered and you will get compensated for the usage of your own car.
In addition to 20 legal days off, you will get 2 extra days and up to 5 seniority days.
Training:
On your arrival and all along your career at COVARTIM you will get many opportunities of learning (technical topics and soft skills).
Well-being at work:
At COVARTIM we care of our members' well-being:
- Attentive director and managers;
- Weekly monitoring of mood and feelings;
- A comfortable, spacious and colorful office surrounded by greenery;
- A good balance between work and life;
- Activities that strengthen group cohesion and make the atmosphere even more pleasant (after-works, team-buidings, table football, sport sessions, …);
- And cherry on top: one well-being workshop per quarter (yoga class, nordic walk, seated massage, cooking class, ...).
Apply
Get to know us better and apply on Welcome to the Jungle :
Or send your application and resume to
Kyun Thibaut
Managing Director
jobs@covartim.com
(30 minutes)
First call with Kyun to make sure that the job meets your expectations and to fix an interview.
(60-90 minutes)
Meeting with Kyun and Arnaud in our office to discuss the job more deeply, to take a quick test (case study) and to discover our office and our team members.
