Master degree in a relevant scientific discipline (including engineer, pharma, biomedical sciences, law) Minimum of 3 years of regulatory or equivalent experience within the medical device industry Experience with the interpretation and application of ISO 13485, Quality System Regulations, Medical Device Directive, and Medical Device Regulation Preferably familiar with medical device (hardware and software) development, risk management, labeling requirements, or clinical evaluation Experience in implementing regulations into workable and efficient processes Excellent technical written and communication skills in English are a must, knowledge of Dutch is an asset Good organizational skills with a pragmatic, hands-on, and flexible approach to your work Able to keep a high level overview of ongoing priorities and can easily coordinate multiple projects within a global context. Must be proficient in MS Office products, including Word, Excel, and PowerPoint You prepare and submit product technical documentation or premarket submissions to obtain or to maintain market authorization for our CE marked, FDA-cleared, and custom-made medical devices. You communicate clearly with internal teams and stakeholders about these submissions and ensure that agreed timelines are respected. You interface with regulatory agencies, such as the FDA, Notified Bodies, and Competent Authorities, and respond to their questions within strict timelines. You guide and review development and engineering activities to assure regulatory compliance during new product development and product changes. You create and maintain the technical documentation of these products. You review and approve labeling and marketing material of the medical devices within your portfolio. You interpret and monitor regulations, guidances, and standards and translate them into efficient internal procedures and processes.