Regulatory Affairs Manager (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 5,000 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 are the contact person for internal and external regulatory inquiries for your area of responsibility.
• As a project leader you create, guide, and drive global RA processes to ensure a smooth collaboration between the RA colleagues in Commercial and R&D.
• You transfer Eppendorf's business needs into the regulatory affairs strategy in close cooperation with the business divisions.
• You are responsible to gather, analyze and continuously assess regulatory market requirements.
• You support/coordinate and execute country and production specific registrations and certifications as needed, including communication with authorities.
• You lead the development and roll-out of RA KPIs for your area of responsibility.
• You prepare and provide trainings with a regulatory focus.

Your expertise

• You have successfully completed a master’s degree in natural science or engineering and have profound professional experience in the field of regulatory affairs with medical devices, electronical parts, preferred in the IVD industry
• You are experienced in international, regulatory environments (e.g. medical devices, IVD, product safety) and you understand and apply the requirements from QM-Systems ISO 13485, US FDA 21 CFR Part 820 Quality and ISO 9001.
• 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 worked in an international organization in the medical-device or laboratory industry and you have a good understanding on the markets and products in the IVD-Med-Tech, Biotechnology and/or Biopharma industry
• You are fluent in German and English.

Your benefits at Eppendorf

• We really appreciate our employees and their performance. This is why we offer an attractive salary and career development opportunities.
• To enable you to deepen your technical knowledge and to continuous development we offer a wide range of trainings and development options.
• By working for us you will make a meaningful contribution to improving human living 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.