Regulatory Affairs Manager (m/f/x) - limited for 2 years

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 make a sign with our innovations and to enable great. Because there are a lot of fascinating people behind every successful company. In an open and modern environment with numerous development and further training opportunities, ZEISS employees work in a culture characterised 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 in less than 10 minutes.

About ZEISS For over 100 years, ZEISS has been shaping progress in medical technology, especially in ophthalmology and microsurgery. Our innovative solutions help to preserve the vision of people and enable targeted interventions on diseased tissue. We support medical professionals worldwide to improve the lives of patients. Our daily drive is the direct influence on the welfare of people.

Your job Preparation and initiation of registration projects for new and existing medical products

Tracking country-specific registration requirements in cooperation with the international ZEISS sales organisations and distributors

Implementation of licensing strategies in global markets.

Compilation and submission of documents from the Technical File for countries with simple registration requirements.

Participation in country-specific documents for markets with low complexity

Processing of feedback from international certification teams and communication to internal interfaces.

Coordination of submission dates and deadlines with international approval teams in the country representations

Reporting on the status of registrations

Identification and implementation of improvements

Completed 4-year study in a technical, scientific, economic or comparable field

First professional experience in Regulatory Affairs in medical technology and knowledge of relevant standards and laws

Basic knowledge of regulatory requirements in markets such as AMERICAS, EMEA and ASEAN.

Embossed analytical skills combined with creativity and intuition

Commitment, willingness to design and strong communication and organisational capabilities in an international environment.

experience in establishing relationships and moderating interest groups, including external partners and regulatory authorities

German and English knowledge in word and writing

Very good knowledge of MS Office and common software tools