Senior Regulatory Affairs Specialist

Job description

About the team and role 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 exter...