Senior Regulatory Affairs Specialist

Are you interested in the future of digital health and medical device innovation and regulation? Come join our fun and dynamic Regulatory Affairs Team. As Senior Regulatory Affairs Specialist, you will play a key role in ensuring that regulatory requirements are in place for our innovative medical device software solutions and intraoral scanner portfolio incl. AI devices. You will be involved in development projects from the start, where your regulatory expertise will be needed as crucial input for the development and market release planning and registration of our devices. You will join our Global Regulatory & Scientific Affairs Department based in 3Shape headquarters in Denmark. Currently, we are 24 people with diverse backgrounds and nationalities at the Danish office in the city centre of Copenhagen. Together with our awesome team in Ukraine, and regulatory colleagues in China, South Korea and Japan we ensure global device registrations. Emphasizing empowerment and taking ownership are key aspects of our culture. Having fun as well. Going to work makes us smile! We enjoy the team spirit and create great results together with our various stakeholders. Regulatory Affairs works closely with many stakeholders across R&D, Marketing, Product Management and sales offices around the globe as well as local external advisors and regulatory consultants. We have great collaboration with the organization and regulatory is seen as a business enabling function. We are also active within advocacy and are involved externally in industry organizations and relevant forums influencing policy work and regulatory frameworks. Join us in shaping a company culture that makes Monday mornings worth it. We are an exciting, visionary, and international place to work. But most of all, we are a diverse group of over 50 different nationalities in our DK office who all contribute to an awesome company culture. We partake in social clubs, monthly Friday social activities, as well as various in-team activities. A joint purpose: to enable dentists to provide superior patient care to every patient, every time.