Boulevard du Souverain 36, Brussels, Belgium
Full time open-ended
The QA/RA Manager shall provide support for the development of innovative medical devices, as part of the COVARTIM QA/RA team. (S)he will manage Quality Assurance and Regulatory Affairs activities such as, but not limited to:
- Quality Management System implementation
- Standards watch and gap analysis
- Audits (internal/external)
- Review and preparation of documentation packages for notified bodies, FDA, competent authorities
Min. 5 years of relevant experience in Medical Devices QA/RA functions.
- 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
- Fluent in English and French/Dutch
- Quality and customer-service oriented
- Focused on details
- Team-player with strong communication skills
- Ability to work cross-projects and excellent organizational skills
- Autonomous and eager to learn
- Strong interest in Lifesciences, Technology and Innovation
- 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!
COVARTIM is the only engineering company 100% focusing on Medical Devices, In Vitro Diagnostic Devices and Digital Health in Belgium.
We support innovators, start-ups and larger companies from the early stages of their product development to the market access by using a hands-on and flexible approach.
Our clients are located in Belgium, Luxembourg, The Netherlands, France, USA, Japan.