Head of 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 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!

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Your Tasks

  • 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.

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 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.
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