Compliance Officer nexuzhealth

Do you have experience setting up and implementing a quality management system? Are you a communicative and driven conceptual thinker? Perfect! Jump on board at nexuzhealth and live it up in the world of compliance and regulation! Nexuzhealth is the Flemish market leader in the management of electronic patient records (EPD). Founded in 2016 by UZ Leuven and Cegeka, it builds on 25 years of development on the Clinical Workstation (KWS) within UZ Leuven. Nexuzhealth thus combines the years of experience of both organizations in ICT and healthcare with the passion of a startup. By offering the collaboration between different hospitals and the patient in a transparent and unambiguous manner, nexuzhealth increases the quality of the care provision. Today, 37 Flemish hospitals and care institutions already work with KWS, accounting for approximately half of the Flemish hospital beds. Patients are also finding their way to mynexuzhealth.be, the platform where every patient from an affiliated healthcare institution can consult his or her own file free of charge. Some 1 million patients already use the file in their contacts with their care team, either via computer or smartphone. #LI-LC1

• Establish and implement a quality management system so that the organization is supported in compliant work.
• Understand and interpret legislation and regulations. You review common practices applied in the medical community. You can translate legal aspects to the technical IT team on the fly.
• You know your way around both local and EU regulations and legislation. You propose strategies to improve efficiency, documentation and reporting.
• You are able to contact other authorities to discuss regulations. Contact with an organization such as 'E-health' does not scare you.
• You advise the different stakeholders and create awareness about all compliance related topics within nexuzhealth.
• You will help colleagues with a technical background to rework internal processes so that they are in line with the questions of an auditor.
• You will provide internal advice to our IT department on how to rework these processes.
• You will work with the team of Medical Device Regulation Officers.
• You will report to the internal Compliance Manager.
• Location is flexible, Leuven, Gent or Hasselt is possible in combination with remote working. For certain meetings, presence at our headquarters in UZ-Leuven is required.

• You are in possession of a Master degree (preferably Law) and have at least a few years of similar experience.
• You have experience with the setting up of a Quality Management System this is a big advantage.
• You like to work in a legal/technical context, not being put off by any technicality is a requirement.
• MDR experience in processes is a bonus.
• You are quick to know how and where to find relevant information and are a strong conceptual thinker.
• You are structured, accurate and work punctually.
• You have a strong sense of self and maintain an open and sincere communication style. Even when you are assertive you do so in a connective manner.
• You speak effortlessly with all levels within the organization.
• You have an excellent knowledge of Dutch and English.
• You have an agile mindset to work in a fast growing and rapidly changing innovative environment.
• You immediately feel at home within the result-oriented, no-nonsense approach of nexuzhealth.