Regulatory Affairs Manager (m/w/d)

New ways to go. But never forget where you come from. Löwenstein Medical has been developing and producing innovative medical technology in Bad Ems for over 30 years. Today, the family-run company is one of the leading medical technology companies in the field of hospital and home care. The commitment of our employees and the high quality of our products ensure a high level of recognition for medical professionals and users. We are looking for a location in Bad Ems Projektmanager (m/w/d)

Creation of registration dossiers for access to international markets (focus on anaesthesia, neonatology and ventilation) Collection of administrative documents (FSCs, legalizations, notary certifications) Monitoring existing international registrations for the timely introduction of registrations Assessment of product changes for international registrations and notification/re-registration of corresponding changes Monitoring regulatory requirements in international markets, evaluation of innovations and communication to internal stakeholders Close cooperation with internal departments (product management, development etc.) and international teams (distribution, service providers, customers and authorities)

Successfully completed scientific or technical studies (e.g. chemistry, biology, medicine, medical technology), as an alternative: comparable qualification and/or long-term experience in the field of Regulatory Affairs Medical technology or training as a medical documentary, etc. with corresponding professional experience Experience in dealing with standards, laws and regulatory requirements Experience with international registrations desirable Good linguistic and written expressiveness in German and English Self-employed, quality-oriented, structured and on-time working Joy in working in the team and on business interfaces as well as communication strength

Family enterprises with flat hierarchies and short decision-making paths Crisis-proof workplace Social benefits (social benefits, social benefits) Grant to the daycare centre Flexible working hours with sliding time control Employee discounts at well-known manufacturers and brands JobRad Special leave Working catering with employer subsidy Staff events (summer festival, Christmas celebration) JOBV1_EN