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

105-202305-7930

(Senior) Regulatory Affairs Manager (f/m/x) (m/w/d)