Regulatory Affairs Experte (m/w/x)

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.

Through the worldwide and cross-industry use of our products and solutions, we are the global brand and the first contact person for new challenges in spectroscopy. With our technologies, optical gratings, spectrometer modules and measurement systems, we not only ensure consistent product quality, but allow our customers maximum efficiency, cost-effectiveness and sustainability in their individual measurement tasks.

At the closest possible time, we are looking for a Regulatory Affairs expert for the areas Agri/Food, Thinfilm and Components (Spektometer/Gitter for OEM) for Carl Zeiss Spectroscopy GmbH in Jena

Your duties You are responsible for product authorisations for international markets Currently it is primarily about Europe and North America, Asia is gradually being built. You define the authorisation strategy, coordinate the authorisation process, check requirements, create or check necessary documents and prepare the declarations of conformity.

You conduct internal audits in the field of product safety and compliance You plan audit cycles, create checklists, conduct discussions with colleagues from the development and derive concrete measures from the results.

You create technical documentation – clean and verifiable This includes, for example, safety data sheets, test reports and conformity declarations. The tools for document steering (DMS) are currently being reassembled together with the IT – your requirements are being incorporated.

You analyze RoHS, REACH & Co. – and implement them specifically. You translate legal requirements into concrete to-dos for development, purchasing and quality assurance – for example through checklists, mandatory fields in ERP systems or new testing processes.

You are the interface between development, quality and external partners In everyday life, this means: clear communication with R&D, close coordination with product management and digital cooperation with external testing bodies and certifiers.

You bring a completed study of natural or engineering sciences, at least on Bachelor level; a master's degree is advantageous.

In addition, you have several years of professional experience in Regulatory Affairs – ideally in the industrial environment

Criteria (special basis for the role) You have a safe handling of the relevant EU directives, in particular the Machinery Directive (2006/42/EC), the Low Voltage Directive, the EMC Directive and the RED.

In addition, you will bring experience in project coordination or the lateral management of employees, for example in the implementation of regulatory requirements in cooperation with development, quality, purchasing or external partners.

Remarkable (but not a requirement) In addition, it is advantageous if you have already gained experience with other standards and specifications such as ATEX, EHEDG, FDA, UL, RoHS, REACH, PFAS bans, the packaging regulation or the battery regulation. However, it is important for us, above all, to prepare for these topics and to apply them in a targeted manner in daily practice.

Working methods and communication Ability to analyse complex legal requirements in a comprehensible manner and translate them into clear processes, workflows and documentation.

Routinized in the creation of technical documents as well as in the handling of audits and conformity documents.

Safe in German and English – in written and oral form – in exchange with internal teams, external inspection bodies and certifiers