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Head of RA/CA/QM (gn) - Job Freiburg - CorTec Stellenportal

Head of RA/CA/QM (gn)

The Freiburg-based high-tech start-up CorTec creates new ways of communication between electrical signals of the body and modern information technology. Our neuromodulation platform technologies and electrodes enable the development of new therapies - in the central as well as the peripheral nervous system.

Our employees embrace neurotechnology in their lives and bring their knowledge to processes and designs to find unique solutions
tailored to our customers' needs.

Great ideas drive us forward - become part of our team and shape the future of neuromodulation with us!

As Head of RA/CA/QM you will be responsible for leading, monitoring, and implementing regulatory, clinical and reimbursement
strategies and processes in the realm of medical technology and clinical processes. You will play a central role in ensuring our products' compliance with national and international regulations, standards, and guidelines. You will lead and manage the Regulatory&Clinical Affairs/Quality Management department. You are member of our Senior Leadership Team.

Your tasks in collaboration with the CEO:

  • Develop and implement a comprehensive regulatory, clinical and reimbursement strategy to ensure our success.
  • Monitor and evaluate laws, regulations, and guidelines pertaining to the medical technology industry on both international and national levels.
  • Prepare and submit regulatory documentation to relevant authorities such as e.g. FDA, EMA.
  • Conduct audits and inspections to ensure that quality assurance and control systems align with regulations.
  • Perform risk assessments related to regulatory matters and develop strategies for risk mitigation.
  • Actively participate in interdisciplinary product development teams to ensure regulatory aspects are considered from the outset.
  • Department management and staff leadership

Your qualifications:

  • Bachelor's or higher degree in fields such as Medical Technology, Biomedical Engineering, Engineering, or a related field.
  • MD possible.
  • Minimum of 5 years of experience in senior positions in the field of medical technology regulation, preferably in an international setting.
  • In-depth knowledge of relevant national and international medical device regulations, standards, and guidelines (e.g., MDR, FDA guidelines).
  • Demonstrated successes in developing and implementing regulatory strategies and submitting approval applications.
  • Leadership experience and excellent skills in team leadership and development.
  • German and English business fluent

Your advantages:

  • Work in a globally active high-tech company with a high level of innovation
  • Collaboration in an active and synergetic team with a pleasant communication culture
  • Growth location with high quality of life in the tri-border region
  • Company health management, Hansefit Membership
Submit application
CorTec ist ein innovatives Medizintechnikunternehmen, das im September 2010 in Freiburg gegründet wurde. Im Sommer 2018 haben wir neue Räumlichkeiten in der Nähe des Airport Campus der Universität Freiburg mit eigenen Reinraumanlagen bezogen.

Als führende Experten für Innovationen im Bereich der Medizintechnik verfolgen wir die Vision, implantierbare Neurotechnologien auf die nächste Stufe zu heben.

Unser Komplettsystem, die CorTec Brain Interchange Platform, sowie deren Komponenten, wie Elektroden oder hermetische Kapselungen, realisieren die Kommunikation mit dem zentralen und peripheren Nervensystem.