Senior Regulatory Affairs Engineer (RA Operations) Europe

In this role, you will define, review, assign, and keep up-to-date necessary codes (EMDN, GMDN, UDI, etc) for our medical devices. You will prepare, review and submit product registrations for applicable markets and obtain and maintain any establishment/operating licenses necessary for the activity as a medical device manufacturer, distributor or importer. Also, ensure reporting of requested information is performed in a timely manner (e.g. for ISO 14001, REACH, RoHS). You will ensure legal representatives are designated, necessary contracts are established, and necessary internal processes are established. Monitor the regulatory landscape to catch new regulations, standards, trends and ensure that impact is analyzed and implemented to keep Neko Health at the forefront of compliance.