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Head of Regulatory Affairs

Job Description

Head of Regulatory Affairs


Your tasks:


·       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.


Your profile:


  • 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.