Head of Global Regulatory Affairs (m/w/d)

Eppendorf is a leading life science company that develops and sells instruments, consumables and services for handling liquids, samples and cells in laboratories worldwide. Eppendorf products are used in academic and commercial research laboratories, for example in companies from the pharmaceutical, biotechnological and chemical and food industries. Working at Eppendorf means being part of a community of more than 5,000 scientists, engineers and specialists from many other disciplines in over 30 countries. We are all committed to a mission: The competent partner and consultant of choice for bioscientific laboratories around the world - with our first-class products, our services and our reliability.

They are responsible for the development and implementation of our regulatory strategy and are responsible for compliance with international standards and regulations at Eppendorf. They run a team of Corporate Regulatory Affairs Manager in a disciplined manner and conduct the QM teams in research and development. They continuously monitor and analyze changes in the regulatory landscape in cooperation with Regulatory Affairs Managers in the Commercial Regions. They develop and implement global regulatory strategies in cooperation with R&D and Business Divisions to support business goals and establish the QMRA strategy. They ensure and integrate regulatory requirements in interdisciplinary teams. They are responsible for product and process compliance during development and life cycle management, including the examination of technical documentation and the preparation of CE declaration. They run the risk management process and optimize the quality management systems according to ISO 9001 and 13485 to ensure the standardization of quality processes. They build relationships with authorities, associations and external partners, as well as monitor and adapt corporate strategies to regulatory changes.

You have a degree in a relevant field, such as engineering, natural science, pharmacy or law. They have several years of experience in Regulatory Affairs and have deep knowledge of global and European regulatory requirements and processes, in particular in handling CE marking and international regulations (e.g. Machine Directive, IVDR, EMC, Low Voltage Directive, Radio Equipment Directive, RoHS, etc.) They have experience in the management and development of teams, both disciplinary and professional. They are experienced in the optimization of quality management processes. They convince by the ability to cross-functional cooperation in a matrix organization, your strong analytical skills and your effective as well as motivating communication skills. They have fluent knowledge of German and English in word and writing.

You work sensuously. Together, we contribute to improving the living conditions of people. We offer you great design space for a strong international premium brand in the Life Science industry. You will receive an attractive remuneration as well as a participation in the company's success. 30 days of vacation per year as well as special days of holidays are of course with us. With our flexible sliding time frame, you can plan your working time individually and design a balanced work-life balance independently. With us you also get the opportunity to work part of your working hours on a mobile basis throughout Germany - just as it fits your life situation. We offer you a variety of social benefits, such as an additional employee-funded pension scheme, business sports, job bike, grant of the ÖPNV, corporate benefits, etc. In order to deepen your knowledge and continuously develop professionally and personally, we offer you a variety of freely selectable training, participation in conferences and access to learning platforms. With us you will find a colourful, open-minded and value-estimating working environment with always current technologies, methods and tools in an environment that also invites you to network. JOBV1_EN