1. RA
2. Belgium
3. Regulatory affairs
Table of Contents
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 do we expect from you as a Senior Expert IVD?
4. You manage projects on clinical evidence and technical documentation. Our customers are mainly non-European manufacturers of IVDs wanting to launch their products on the European market You write and review clinical evidence documentation and technical documentation of our customersYou are in charge of the technical preparation of the file before sending it to the notified body to obtain CE-marking You are responsible for the project management of the assigned projects: communication with customers, planning of the project, monitoring timelines and budget for guiding and coaching project team members. You review project deliverables to ensure constant quality and consistency.
5. You support our customers with tailored advice on clinical evidence strategies (incl. analytical and clinical performance) and technical documentation
6. You support customers during the development of their IVDs, from feasibility to launch
7. You support companies in their transition from IVD Directive to IVD Regulation
8. You maintain, develop and share your expertise and knowledge on Clinical Evidence
9. Support our marketing activities, such as writing blogposts, white papers, present webinars, …
10. Act as expert during sales meetings and prospective calls
Who are we looking for?
11. You have a PhD or a Master’s degree in sciences or technology (biomedical sciences, biology, pharmacy,…)
12. You have experience with assay development and (analytical & clinical) assay validation in an R&D environment
13. Experience with EU or US IVD Regulation is a strong plus
14. Knowledge of risk management and post-market surveillance is a plus
15. You own a strong customer focus, autonomy and sense for quality
16. in regulatory affairs in IVD, MD or biotech industry
17. You are a strong communicator, a decision make r, and administratively skilled
18. You enjoy working in an international environment
19. You are organized and flexible
20. You have excellent English verbal & written communication skills
21. You have (medical) writing skills and an analytical mindset
22. Affinity with project management
23. A true QbD’er can be recognised by the following qualities: Resilient: Your strong and positive attitude helps you overcome any challenge Hungry for knowledge : You are always open to learning No nonsense mentality : you can be straightforward in a respectful way Innovative: You are constantly looking for new and better solutions (Not too) serious : your job is serious, but you don’t take yourself too serious.
What does the QbD group offer you?
As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
Even more, we offer:
24. Room to shape and implement your strategic regulatory stamp and have impact
25. A full-time and long-term commitment
26. A sustainable career filled with meaningful connections on international level within a knowledge-based company
We go and stand for JPEG : J oy in P artnership, going for the E xtra mile to G et things done!
Interested?
Send us your CV and motivation letter and who knows, we might welcome you soon!