Device Compliance Expert

Device Compliance Expert

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Qarad, part of the QbD group, is a fast-growing consultancy company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. 
Our objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. We help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). We are also authorized representatives for non-EU manufacturers and offer a unique solution for e-labelling, currently used by multi-billion-dollar medical device and IVD companies.

 

What are your responsibilities?

  • Writing and reviewing of clinical evidence documentation and technical documentation of our customers
    • Our customers are mainly non-European manufacturers of IVDs wanting to launch their products on the European market
    • You are in charge of the technical preparation of the file before sending it to the notified body to obtain CE-marking 
  • You support our customers with tailored advice on clinical evidence and technical documentation
  • Communication with the customer on the status of the project

Who are we looking for?

  • You have a PhD or a Master’s degree in sciences or technology (biomedical sciences, biology, pharmacy,…)
  • You have experience with assay development and (analytical & clinical) assay validation in an R&D environment
  • You preferably have a first experience in regulatory affairs in IVD, MD or biotech industry
  • You have excellent English verbal & written communication skills
  • You have (technical) writing skills and an analytical mindset
  • You are a strong communicator, a decision maker, and administratively skilled
  • You enjoy working in an international environment
  • You are organized, flexible and customer focused

What does Qarad, part of the QbD group, offer you?

The QbD group is a healthy international company with strong growth ambitions (organic and inorganic). In addition to a competitive salary package, we can offer you:

  • The chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics
  • A company with a clear strategy and ambition
  • The opportunity to use and develop your skills in a world class team of specialists
  • Standing still means going backwards. With our extensive training package and our periodic knowledge-sharing moments, we offer you many opportunities to continuously learn, to expand or specialize your knowledge and skills and to gain new expertise
  • Thanks to our flat organization, we have short communication lines
  • You’ll work in an award winning company:
    • Our CEO, Bart Van Acker, became Flemish Young Entrepreneur of the year 2019, which means that you’ll be part of a vibrant, entrepreneurial organization.
    • We were elected as Best Managed Company by Deloitte in 2020 & 2021
    • We hold the Baanbrekende Werkgever 2022 certificate (Pioneering Employer) 
    • Nominated as Trends Gazelle 2022 – Large Companies
  • Working in a value driven and data driven company where a people centric approach and business go hand in hand
  • We can only put the best of ourselves in our daily work when you also have some fun in the meantime and can build sustainable relationships with your colleagues and partners. We take care of JOY: Trans Alpes Nice Genève with our cycling team, triathlons, (trail) runs, parties and after works, our legendary annual weekend, charity events, … Get to know your colleagues outside the work environment!
  • In short… We go and stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done!

Interested? Send us your CV and motivation letter and who knows, we might welcome you soon!

 

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