Regulatory Affairs Manager Software (m/f/d)

Trust something new, grow beyond itself and redefine the boundaries of the feasible. That is exactly what our employees can and should live daily. To set the pace with our innovations and make it great. Because there are a lot of fascinating people behind every successful company. ZEISS employees work in an open and modern environment with numerous development and further training opportunities. Our culture is characterized by expert knowledge and team spirit. All this is supported by the special ownership structure and the long-term goal of the Carl-Zeiss Foundation: to advance science and society together.

Today dare. Inspire tomorrow.

Diversity is part of ZEISS. We look forward to your application regardless of gender, nationality, ethnic and social origin, religion, world view, disability, age as well as sexual orientation and identity.

Apply now! In less than 10 minutes. Definition and implementation of regulatory international licensing strategies for complex, demanding development projects for innovative medical software solutions in ophthalmology and neurosurgery.

Testing and approval of product-specific marketing materials

Continuous collaboration in project teams for product new and further developments from product definition to market launch

Cooperation with projects for authorisations or changes in legislation (e.g. EU MDR, FDA, NMPA)

Promote the implementation of digital medical devices in markets with divergent registration requirements and create independent submission dossiers for global markets

Monitor, maintain and report approval status

Close cooperation with internal areas (R&D, project management, product management, marketing communications, clinical affairs, international RA contacts in the respective markets) and with external authorities and partners

Promoting the optimization of global regulatory affairs processes

Successfully completed higher education in a technical, economic, business or comparable course Active and extensive professional experience in Regulatory Affairs in software products in medical technology or comparable professional experience Analytical skills and creativity as well as communication strength and organizational talent in an international environment Project management experience and knowledge of economic relationships Self-employed and solution-oriented work Very good knowledge of English and German in word and writing; further language skills are advantageous Very good knowledge of MS Office and common software tools