Clinical Affairs Manager

Location

Boulevard du Souverain 36, Watermael-Boitsfort, Belgium

Function type

Full time open-ended

Job description:

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
  • Preparation of CEP and CER
  • Set up and follow up of PMS, PMCF, PSUR
  • Review and preparation of documentation packages for notified bodies, FDA, competent authorities

Background:

Min. 5 years of relevant experience in a Medical Devices clinical function.

Hard skills:

  • Good knowledge of medical devices and IVD regulatory environment (directives, regulations)
  • 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
  • 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’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!

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.

Apply here!