Medical Devices QA/RA Manager

12/01/22

Location

Boulevard du Souverain 36, Watermael-Boitsfort (Brussels), Belgium

Function type

Full time - Open-ended

Vacancy

Job description:

The Medical Devices 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

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

Our offer:

  • The opportunity to contribute to the development of products that will improve or save people‚Äôs 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!

About us:

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.

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