Head of Regulatory Affairs (m/f/d)
- Careerlevel: Direct Entry
- Employment: full time, permanent
- Start: immediately
- Location: Hamburg
Would you like to work for a company who has made it its mission to make a contribution to improving human living conditions? With more than 3,600 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 responsible to provide regulatory input to new product developments and product lifecycle planning for our Eppendorf products.
- You are leading the Corporate Regulatory Affairs team.
- 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 develop multi-country regulatory strategies to support the business-
- You work together with the corporate RA team as well as the local market RA colleagues to identify market requirements and support local submissions.
- 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 within the Medical Device industry – preferred in the In Vitro Diagnotic industry.
- You understand the requirements from Quality Systems 13485, US FDA 21 Part 820
- You have experience in Clinical & Regulatory Development Management.
- 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.