YOUR MISSION

We want you to join our early-stage university spin-off that has just received its ISO 13485 certification. As an integral part of our team, you will harness your regulatory expertise to …

• … develop and implement the regulatory strategy for FDA clearance (De Novo) and conformity assessment under MDR (class II).
• … create, manage, and maintain regulatory documentation for US and EU submissions.
• … provide Regulatory Affairs expertise to support development and change initiatives.
• … coordinate the scheduling and planning of RA-related work and resource allocation.
• … plan and contribute to clinical evaluation activities, including CEP/CER and post-market surveillance.
• … lead regulatory submissions and interactions with authorities for our SaMD product in an evolving software and machine learning regulatory landscape.
• … collaborate cross-functionally with QA, product, clinical, and engineering teams to ensure regulatory alignment.

ABOUT US

We are a Munich-based startup building a digital twin platform for respiratory diseases – a monolithic digital toolset that elevates the actions of decision makers in healthcare and life sciences through physics-based simulation, AI, and data science. In the hands of industrial users, it fosters their understanding of pulmonary drug delivery to inform, accelerate and de-risk trial design and execution. In the hands of physicians, it will offer personalized treatment perspectives to improve the odds of survival and recovery in millions of cases of respiratory complication each year, such as Acute Respiratory Distress Syndrome (ARDS). Anywhere at any time

Please refer the Job description for details