fbpx (Senior) Regulatory Affairs Manager (f/m/x) | home of jobs Direkt zum Inhalt


  • Master or comparable academic degree in business administration or engineering
  • Long term experience within Regulatory Affairs in Medical Technology or similar areas; broad project management experience
  • Experience in registration of medical devices
  • Analytical, systematic and goal-oriented approach
  • Experience in communicating and solving of complex tasks in matrix organizations
  • fluent English other languages are a plus


  • Prepare international cross-department registration projects for non-active medical devices in ophthalmology risk class I to III: Analysis of approval-relevant requirements and discussion of implementation options with interfaces and independent deriving of registration strategies
  • Plan and lead complex registration projects, implement concepts and planned measures to ensure approval
  • Collaborate in cross-site projects for new registrations, registration of product changes or regulation induced changes
  • Continuously analyze and optimize Regulatory Affairs processes in close cooperation with involved departments, e.g. Clinical Affairs, Research & Development, etc.
  • Work in an international team of Regulatory Affairs Managers who, together with Business Management and Logistics, ensure the market availability of our products


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