Head of Global Regulatory Affairs (m/f/d)
- Career level: Direct Entry
- Employment: Fulltime, permanent
- Start: 01-01-22
- Location: Hamburg
- Job-ID: R3257
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 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.
- 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.Apply now
We look forward to meet you!
If you have any questions please contact: