Regulatory specialist in translational MedTech project (internship)


ReflectUS, an ETH Zurich Spin-Off project, in collaboration with the Computer-assisted Applications in Medicine Group, is developing a new diagnostic device for breast cancer based on innovations in ultrasound imaging. ReflectUS enables women of all ages to receive safe and reliable breast cancer diagnosis without radiation and discomfort. Our technology is the winning technology of the Spark Award 2016 (https://www.ethz.ch/spark-award).

The next project stage will translate our benchtop prototype into a clinical product.

We are searching for a motivated candidate willing to join our team as:

Regulatory specialist in translational MedTech project (internship)

The tasks involve implementing a Quality Management System for the medical device start-up according to EN ISO 13485 and supporting applications for upcoming clinical studies. The candidate will define together with the R&D team quality control processes in the design process (software, physical sensors, data management), build Standard Operating Procedures (SOPs) for CE mark approval and prepare documentation for clinical studies (protocol, case report, ethic approval). Subsequently, the candidate will also assist in interpreting and validating collected data in the developed framework.

To carry out the above tasks, we are looking for a candidate with interest in Quality Systems and Control and a medical and/or technical background (for instance, Biomedical Technology, Physics or Computer Science). The successful candidate is a fluent writer in both English and German, with excellent summarization and reporting skills. Prior experience in clinical studies and/or medical imaging technologies (ultrasound, X-ray) is preferential. Knowledge in medical statistics and software processes are a plus. A self-starter goal-oriented personality with rounds up the profile.

We offer exposure to an exciting mixed clinical-technological project, access to professional regulatory consultants and experienced med-tech coaches and the opportunity to grow within a new creation start-up.

Preferred starting date is a soon as possible. We offer an employment of 3 to 6 months, with possibilities for extension.

Please submit your application to Dr. Sergio Sanabria (ssanabria@ethz.ch), including a comprehensive CV and motivation letter.