Regulatory Affairs

What we do

The Regulatory Affairs team is growing rapidly as is the company’s requirement for a faster time to market for its solutions. Our responsibilities include obtaining and maintaining regulatory approvals for 3Shape 3D scanners and software medical devices as well as providing global registration support for the organization.

By interacting with a wide range of stakeholders -especially R&D, Product Management, global sales offices and external consultants - we are supporting and monitoring the development of future disruptive health technology.

Our team

Our team consists of Regulatory Affairs Specialists, Product Quality Managers, and Scientific Managers with diverse backgrounds. We are located in Denmark, Brazil, Korea and Japan.

Our people love working here

As a regulatory affairs specialist in 3Shape, you work with different departments and teams. It creates a very diverse set of tasks, which I like. There are moments when you need to step out of your comfort zone and try new ways of understanding and solving problems.

Ewa Wybraniec Regulatory Affairs Specialist

I get to work with cutting edge tech and the latest in the regulatory affairs landscape. It is super exciting to bring truly novel dental technologies to global markets.

Shreyosi Chakraborty Regulatory Affairs Specialist