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

Would you like to work for a company who has made it its mission to make a contribution to improving human living conditions? With around 4,500 employees worldwide Eppendorf is a leading Life Sciences company. We develop and distribute devices, consumables and services for use in laboratories worldwide. Our daily work is characterized by our principle: Collaborate on new ideas. You would like to take responsibility and help to make a difference in an experienced international company? Exciting tasks combined with a positive and affirmative working environment await you at Eppendorf. You are also motivated by technical challenges? Then apply now!

Your challenges

• You lead the corporate regulatory affairs team and provide regulatory input to new product developments and product lifecycle planning for our Eppendorf products.
• You foster and maintain the RA network consisting of the RA matrix organization and its collaboration bodies (i.e. CoPs, Business Partner and SMEs).
• You drive the development, improvement and implementation of regulatory processes and procedures as well as the harmonization of processes within the global RA organization of Eppendorf.
• You transfer Eppendorf’s overall strategies into RA guidelines to support the business.
• You lead the development and roll-out of RA KPIs.

Your expertise

• You have successfully completed a master degree in natural science / engineering and have at least 5 years professional experience in the field of Regulatory Affairs with medical devices, electronical parts, preferred in the In Vitro Diagnotic industry.
• You understand the requirements from Quality Systems 13485, US FDA 21 Part 820, GMP
• You have a good understanding of the IVD-Med-Tech, Biotechnology and Biopharma industry, the related markets and products.
• You combine comprehensive regulatory knowledge e.g. guidelines, policies and requirements of applicable product laws with a strong project management experience, especially with supporting new product developments and launches.
• You have sound German and English language skills.

Your benefits at Eppendorf

• We really appreciate our employees and their performance. This is why we offer an attractive salary.
• You will also have the opportunity to work from home – in a way that suits your personal situation best.
• By working for us you will make a meaningful contribution to improving human iving conditions.
• At our locations in Hamburg, Leipzig and Oldenburg i.H. you can also benefit from a subsidized lunch in the company restaurant.

Please note that we can only consider applications that are submitted online via our application management tool.