Head of Regulatory Affairs
· Technical and disciplinary management of employees in the Regulatory Affairs EU/EMEA group
· Ensuring compliance with MDR requirements for product certification and re-certification, registration, and re-registration of medical devices
· Responsibility for change management on the part of RA
· Communication with notified bodies and authorities
· Collaboration and coordination with other business areas on strategic regulatory issues for new developments and legacy medical products
· Regulatory support of the development process of medical devices
· Defining and ensuring compliance with requirements for merchandise products
· Analysis and interpretation of (inter-)national regulatory requirements and practical implementation of the requirements
· Active participation in the design, implementation and improvement of processes, improvement of existing ones and creation of SOPs and work instructions
· Planning projects and reporting project progress in responsibility
· Definition of the requirements for internal company databases, coordination of commissioning as well as development and improvement of processes for their use
· Representation of the Regulatory Affairs department in audits by authorities and notified bodies for the area of responsibility.
You have successfully completed a degree in natural sciences or engineering and have several years of professional experience in a regulatory environment.
You are familiar with relevant national and international medical device regulations.
You work independently, enjoy structuring things, and have a good eye for details.
You enjoy working in a team and can inspire others to take on tasks.
You have initial leadership experience or would like to develop further in this direction.
You are familiar with entrepreneurial thinking.
You enjoy using databases and IT systems.
You have a very good command of German and English, both spoken and written.