Materialise is a dynamic international high-tech company, founded in 1990 and headquartered in Belgium, with over 1,500 employees worldwide. Materialise’s mission is to innovate for a better and healthier world through its software and hardware infrastructure and in-depth knowledge of additive manufacturing (also known as 3D Printing). Our customers are in diverse industries, such as automotive, aerospace, medical, research and academia.
As a growing company, Materialise is always looking for enthusiastic professionals who want to work in an environment full of revolutionary technology and surrounded by people passionate about their work.
As the Regulatory Officer, you are responsible to obtain the necessary registrations and European and US market clearances for our medical solutions. Based on a list of priorities agreed with the business unit, you will work to meet the regulatory requirements to do business: you will analyse the applicable regulations, define product registration strategies and work together with a wide range of teams to generate and review product documentation to ensure a timely market access for our medical solutions. You will be responsible to follow-up changes in regulations that affect our medical solutions.
Furthermore, you are involved in regulatory operations projects: in line with our Year Plan, you contribute to the team efforts to implement new concepts that shape the regulatory landscape. These include the EU Medical Devices Regulation, the organization of Clinical Evaluation, medical device labeling activities, etc. You report to the Regulatory Affairs Manager.