Regulatory Affairs Manager (m/f/d)
- Career level: Direct Entry
- Employment: Fulltime, permanent
- Start: 01-10-22
- Location: Hamburg
- Job-ID: R5113
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!Apply now
- You are the contact person for internal and external regulatory inquiries for your area of responsibility.
- You are responsible to gather, analyze and continuously assess regulatory market requirements.
- You drive the RA related processes to ensure a smooth collaboration between the RA colleagues in Commercial and R&D
- You support/coordinate and execute country and production specific registrations and certifications as needed, including communication with authorities
- You guide and drive the global implementation of regulatory requirements.
- You apply your RA knowledge and anticipate potential consequences for Eppendorf processes.
- You lead the development and roll-out of RA KPIs for your area of responsibility.
- You prepare, organize and assist with audits by notified bodies and authorities.
- You prepare and provide trainings with a regulatory focus.
- 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.
We also welcome applications from candidates who are at the beginning of their professional careers within the Regulatory Affairs sector and offer appropriate development opportunities.
Your benefits at Eppendorf
- We really appreciate our employees and their performance. This is why we offer an attractive salary.
- 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.Apply now
We look forward to meet you!
If you have any questions please contact: