Head of Global Regulatory Affairs (m/f/d)

Crossed

Eppendorf is a highly innovative life science company based in Hamburg, Germany. Since 1945 Eppendorf develops customer-oriented solutions for liquid handling, cell handling and sample handling. Today, Eppendorf and its more than 4,500 employees serve as experts and advisors, using their unique knowledge and experience to support laboratories and research institutions around the world. The foundation of the company’s expertise is its focus on its customers. Eppendorf’s exchange of ideas with its customers results in comprehensive solutions that in turn become industry standards. Eppendorf will continue on this path in the future, true to the standard set by the company’s founders: that of sustainably improving human living conditions.

Your challenges
  • 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.

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 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.

Daten

Unternehmen: Eppendorf SE

Art der Beschäftigung: Stellenangebot

Befristung: Unbefristet

Bereich: Sonstiges

Einsatzort: Hamburg

Beginn: 01.03.2022

Wochenstunden: Vollzeit

Kontakt

Eppendorf SE

Ansprechpartner: Malin Holm

E-Mail: holm.m@eppendorf.de

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