MedTech Clinical Affairs Manager
MedTech Clinical Affairs Manager
Boulevard du Souverain 36, Watermael-Boitsfort (Brussels), Belgium
Let's introduce ourselves!
COVARTIM is a Belgian engineering company. We help startups, SME's and healthcare practitioners develop medical technologies (medical devices, in-vitro diagnostic medical devices and medical software). Our company is unique in Belgium. Our expertise is well recognized by our clients and partners. We have an international reach with clients based in BeNeLux, France, US, Brazil and Japan.
Our company is structured into two teams: the Product Development team and the Quality Assurance/Regulatory Affairs team. Both interact on every project of the company.
Our workplace is nice and comfortable (our Chief Plants Officer takes care of its greenery!). It is close to many commodities (public transport, restaurants, bakeries). The nearby forest and park offer nice spots for a run or a walk during lunch breaks.
How we see the job:
The Clinical Affairs Manager shall provide support for the development of innovative medical devices, as part of the development team within COVARTIM. (S)he will manage Clinical Affairs activities such as, but not limited to:
Preparation of CEP and CER
Management of clinical investigation
Set up and follow up of PMS, PMCF, PSUR
Review and preparation of documentation packages for notified bodies, FDA, competent authorities
You would need hard skills ...
Good understanding of medical devices and IVD regulatory environment
Good knowledge of medical devices clinical investigation clearance process (EU and US)
Good knowledge of medical devices risk management, CIP, CIR, CEP, CER, PMS, PMCF, PSUR
English and French/Dutch
and soft skills
Passionate about Lifesciences, technology and innovation
Quality and customer-service oriented
Strong communication and organizational skills
Autonomous & Quick learner
Flexible & open-minded
What we are offering you:
The opportunity to contribute to the development of products that will improve or save people’s life
A valorizing job within an ambitious and growing company in a booming industry
A great team of enthusiastic people led by passionate experts in MedTech
A nice working environment in our new office located in Brussels, close to the forest of Soignes, a park, nice shops and restaurants, public transport connections and the E411
And of course, a good salary package and extra benefits!
Why you should join us:
COVARTIM is a young company in full bloom; help us shape its future! Be part of it!
Be visible and evolve:
Your work is highly visible to everyone in the company but also to the clients for whom you rapidly take the lead and become their project responsible. Over time you gain autonomy and become the leader of your own projects. The more you grow, the more responsibilities you get with regards to our client's projects as well.
Take a tour around:
You work on several projects in parallel meaning that, in a very short period, you get to see a lot of different devices at different development stages. You can either become an expert in a specific field or be a generalist.
Develop your skills and stay up-to-date:
Training and regulatory-market-technology watch help you remain at the state of the art of technologies and methodologies.
Feel like home:
Do not feel left out on a client’s site; work with your colleagues from our office in Brussels.
Your team manager follows you, reviews your workload and your project priorities and assesses your work every 6 months.
Get in touch!
Apply today and hear from us very soon!