Performance Evaluation Studies Expert
il y a 4 semaines
Table of Contents
Are you excited about science and technology? Do you love to dig into scientific data to investigate the performance of that new diagnostic test? Do you enjoy coordinating and making sure the job gets done according to plan? Are you looking for a job that allows you to help other people and work in a team of dedicated peers? Would you like to help IVD manufacturers to bring high quality products to the market? Then we’re looking for you
Who are we?
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 representative 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 Performance Evaluation Studies Expert?
As a Performance Evaluation Studies expert you will coordinate different performance evaluation studies to ensure that all related tasks are carried out in a timely manner and in agreement with protocols, contracts and relevant regulations and/or guidances: Drafting of evaluation protocols Training and monitoring of the study sites Data source verification and data analysisCompilation of performance study reports You discuss the status of the projects with the customers and you communicate with the study sites to ensure a smooth, accurate and qualitative execution of the studies
Who are we looking for?
You have a Master’s degree in sciences or technology (biomedical sciences, biology, pharmacy,…) or equivalent by experience. A PhD is an advantage but not a prerequisite. You have relevant experience in IVD or biotech industry (such as experience with assay development and (analytical & clinical) assay validation ) You preferably have experience in regulatory affairs or have worked in a quality-driven environment (ISO) You have experience and affinity with study designs, scientific data analysis and reporting You have excellent English verbal & written communication skills You have (technical) writing skills and an analytical mindset without losing track of the bigger plan You enjoy working in an international environment 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 BS 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 QbD group offer you?
An attractive and complete salary package:
A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.But most of all…
We offer sustainable careers and meaningful connections We are a knowledge based company You’ll work for an award winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, …Our promise to you:
As an ambitious and pioneering company , we want to offer you the best possible environment to thrive within the life sciences. You’ll get the chance to acquire a broad knowledge in the fast-growing area of in vitro diagnostics 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. In short … We 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, maybe you’ll find your #QbDream job.
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