The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
With the founding of the Else Kröner-Fresenius-Center for Digital Health (EKFZ) at the Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden (TUD) as one of Germany's universities of excellence develops a strategic focus at the interface of high tech and medicine. As part of the establishment of the center a
Chair (W2 / W3) for Medical Device Regulatory Affairs (f/m/x)
is to be filled as soon as possible.
Regulatory factors play an increasing role in the transfer of high tech innovation to the patient, raising a number of highly relevant research questions: How can the increasing complexity of medical devices and the speed of innovation on the one hand and the safety of patients on the other hand be optimally reconciled? Which components of current regulatory framework really contribute to patient safety in a European and international context? How can approval processes be made more efficient and safer? What effect has the use of artificial intelligence and cloud solutions in medical devices (on what: patient safety, amendments of regulations?)? We are looking for an innovative personality who strives to find answers to these questions through research and who initiates an active research agenda in this field. You enjoy working in an interdisciplinary environment with physicians, engineers, economists and social scientists and will participate in innovative teaching formats in medicine and in biomedical engineering. We also expect you to be willing and able to teach courses in English and German and to participate in academic selfadministration. Our TUD campus is international and proficiency in German is not a prerequisite for appointment. As holder of the chair you will work closely together with consulting infrastructure and inhouse CE certification support for the innovation teams of the EKFZ and will also be responsible for shaping public discussion and providing policy advice.
According to §58 SächsHSFG requirements for an appointment are a university degree and an outstanding doctorate in engineering, law or related disciplines, didactical experience and specific research performance relevant to the call. This is usually proven by a habilitation or equivalent academic achievements, which may also have been achieved in activities outside the university sector or within the framework of a junior professorship. We also expect you to have concrete practical experience in certification processes for medical devices and have your strengths in the fields of medical device law and CE certification. If you have any further questions, please contact the head of the selection committee, Prof. Dr. Jochen Hampe (phone: 0351-458-5643; e-mail email@example.com).
TU Dresden seeks to employ more female professors and particularly encourages women to apply. Applications from candidates with disabilities or those requiring additional support are also very welcome. The University is a certified familyfriendly university and offers a dual career service. If you have any related questions, please contact the equal opportunities officer of the Faculty (Dr. Valtink, phone: 0351-458-6124) or the representative of employees with disabilities (Ms. Vogelbusch, phone: 0351-458-12127).