As a Regulatory Consultant Medical Devices, you ensure compliance of documentation and QMS with the relevant ISO standards, Directives, Regulations and Guidance Documents. For medical devices, combination/borderline products or IVDs. Whether it concerns ISO 13485 auditing, writing and composing technical files or managing the approval process with the notified bodies; You work in a team with the experience and dedication to support the customer. You value a personal approach with attention to the client's needs. Furthermore, you will work on the following: CE classification, Competent authorities interactions, ISO 13485 QMS, Regulatory strategy plan and MDR gap analysis.