Quality Assurance / Regulatory Manager  

Medical Devices - Vitro Diagnostic Devices - Digital Health

About Us

Our client is a great engineering company 100% focused on Medical Devices, In Vitro Diagnostic Devices and Digital Health in Belgium.

They 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.

They are based in Brussels in a green and peaceful setting.

Medical Devices QA/RA Manager

The QA/RA Manager shall provide support for the development of innovative medical devices, as part of the QA/RA team.

(S)he will manage Quality Assurance and Regulatory Affairs activities such as, but not limited to:

• Quality Management System implementation at our clients’ site
• Standards watch and gap analysis
• Audits (internal/external)
• Review and preparation of documentation packages for notified bodies, FDA, competent authorities 

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
• Used to work in a start-up environment 

Soft Skills

• Passionate about lifesciences, technology and innovation
• Quality and customer-service oriented
• Focused on details
• Strong communication and organizational skills
• Autonomous & Quick learner
• Flexible & open-minded

The Offer

• The chance to contribute to the development of products that will improve or save people’s life
• Full-time open-ended contract
• Good salary package
• Valorising work
• Very nice working atmosphere