Senior) Regulatory Affairs Expert

vor 1 Tag

München, Deutschland Ebenbuild Vollzeit

**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.

**Your profile**:

- Completed university education in a technical, scientific, or comparable field of study.
- 5+ years of experience in regulatory affairs for medical devices, with a focus on software products (SaMD).
- Proven success with FDA (510(k)/De Novo) and MDR Class II submissions.
- Strong knowledge of 21 CFR Part 860/807/812, FDA Guidance, MDR, and clinical evaluation processes
- Strong analytical skills combined with creativity and intuition.Excellent written and verbal communication skills in English. German is a plus.
- Independent and solution-oriented approach to work.
- Hands-on, structured, and comfortable working in a dynamic startup environment.

**Why us?**:

- Central office in the heart of Munich
- Hybrid role with flexible work-from-home scheduling
- Build products that will have a measurable impact on the lives of patients
- Play a leading role in shaping the path to the market for a highly innovative software product
- We are an interdisciplinary team of highly motivated, skilled, and ambitious people. Individual contributions count a lot

**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.

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