Senior Regulatory Affairs Specialist (d/f/m)

at  Essity

SENIOR REGULATORY AFFAIRS SPECIALIST (D/F/M)

Essity is a leading global hygiene and healthcare company . We are committed to improving the quality of life through high-quality hygiene and healthcare solutions . We sell our products and solutions in around 150 countries under many strong brands , including the global market leaders TENA and Tork , as well as well-known brands such as Jobst , Leukoplast , Libero , Libresse , Lotus , Nosotras , Saba , Tempo , Vinda and Zewa .
For our Regulatory Affairs department we are looking for an senior expert in the to support our team as soon as possible .

• Initiate and drive process improvement activities for medical device related local document control activities within a regulated environment ( e.g. Medical Device Regulation 2017/745/EU)
• Formal check and approval of documents and templates
• Ensure the activities of other departments involved in releasing/changing controlled documents adhere to document control prerequisites
• Maintain UDI activities for implementation, e.g. responsible for defining UDI attributes in the documentation management system (SAP)
• Maintain classifications in SAP and apply/change SAP attributes, SAP user management and first level problem support for medical SAP user
• Prepare and conduct SAP trainings