- - The site of employment is Geel but working remotely can be considered. Belgium
QA/RA in IVD
The company is a fast-growing consulting company assisting manufacturers of In Vitro Diagnostics (IVD) and Medical Devices (MD) in coping with European and other regulations. Their objective is to provide manufacturers with practical solutions in the area of regulatory affairs and quality assurance. They help with the implementation of quality systems, technical documentation and the organization of performance evaluations (clinical studies). They 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 their offices in Geel, Eindhoven, Turin and other international locations the company serves more than 250 customers worldwide.
This is what you will be doing
Due to continuing strategic growth, the company will be looking to expand our Device Compliance Department over the coming months. The company is looking for consultants at different career levels with experience in regulatory affairs, quality assurance, clinical affairs or medical devices and IVD.
For a specific large project we are looking for an IVD expert with project management experience.
The role includes, but is not limited to, the following accountabilities:
You are responsible for a large scale project in the IVD industry
You are responsible for planning of the project, monitoring timelines and budget
You will communicate both internally and externally on the progress of the project and address any issues adequately
You will be coaching and steering the project team members
You review the project deliverables to ensure quality and consistency. The project deliverables consist of Technical Files for IVDs
You perform the technical writing of parts of the technical documentation, such as risk management reports, State-of-the-Art, …
You guide and consult the customer in the implementation of the IVD-R and the compilation of technical documentation.
This is what you will bring
The perfect candidate (M/F) has a degree in sciences and has an excellent understanding of IVD as demonstrated by a minimum of 5 years of experience in an IVD company, clinical laboratory or similar environment.
Experience with IVD assay development or validation is an important advantage. Understanding analytical and clinical performance of an IVD assay is a must.
In addition, you have affinity with project management. Experience with project management software is an advantage.
Our candidate combines strong analytical skills with project management skills. He/she has excellent communication skills, both in communicating with stakeholders and in coaching team members. He/she works proactive, autonomous, organized and is a teamworker. He/She enjoys working in an international context. He/She understands that working in a small team requires a flexible attitude.