Device compliance assistant
Device compliance assistant
- - The site of employment is Geel but working remotely can be considered. Belgium
QA/RA in IVD
Qarad is a fast-growing consulting 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-labeling, currently used by multi-billion dollar medical device and IVD companies. From our offices in Geel, Eindhoven, Turin and other international locations we serve more than 250 customers worldwide. Due to continuing strategic growth, Qarad will be looking to expand the Device Compliance Department over the coming months. The Device Compliance Team at Qarad provides support to manufacturer's of IVDs on the generation of technical documentation. Our services include the composition and/or review of the entire technical documentation of IVDs in accordance with the European IVD Regulation. In addition, we provide technical and regulatory consulting to our customers on various IVD-R related topics.
This is what you will be doing
The role includes, but is not limited to, the following accountabilities:
- Writing reports (in English) on the performance of IVD assays, based on study data, literature and other data sources
- The review and analysis of analytical and clinical performance data and other sections of technical documentation of IVD assays
- Writing of various sections of the technical documentation for product certification
- Interact with international customers on the points above
- Performing literature searches and writing reports on the scientific validity of analytical markers in IVD assays
Depending on the experience of the candidate, these tasks can be performed independently or in collaboration with colleagues.
This is what you will bring
- Holding a university degree in biology, biochemistry, bioengineering, biomedical sciences or pharmacy
- Experience IVD assays development or validation is an important advantage
- Fluently communicates in English and preferably other languages
- Excellent writer in the English language
- Strong analytical skills and an eye for detail.
- Experience with literature searches is an advantage
- Enjoys working in an international context
- Eager to learn
- Likes variation in handling several projects at the same time
- Understands that working in a small team requires a flexible attitude.
- Knowledge of and experience with analytical laboratory techniques is an advantage but not a pre-requisite