QA/RA Manager
Functieomschrijving
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
Location
Boulevard du Souverain 36, 1170 Watermael-Boitsfort (Brussels)
Function type
Full time open-ended
Background:
Min. 5 years of relevant experience in Medical Devices QA/RA functions.
Hard skills:
- 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
Soft skills:
- 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
Ons aanbod
- 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!
Solliciteer
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