Regulatory Affairs (RA)
There are many opportunities if you want to work with regulatory affairs in the medtech industry. Typically, this line of work is employed by engineers, jurists or people with a master’s degree in Science or Business Economics.
Working within regulatory affairs in the medtech industry, you will be examining how a product failure arises – how the production itself can fail, and how the product can fail during usage. Along with the rest of the QA-team, you will be investigating the risks associated with a specific product, in order to develop a product that is optimal and safe to use.
Besides that, the product needs to be approved by the government. The government will be basing their approval on a variety of documentation- and product regulations. You need to know about these regulations, and you need to make sure that the product, from the development phase to the manufacturing phase, is meeting all the requirements.