Quality & Regulatory Affairs (QRA) Specialist (FT - Remote Europe)

QRA Specialist

Ikerian AG (formerly RetinAI Medical) is a fast-growing medical device software company headquartered in Bern, Switzerland. Our mission is to enable the right decisions sooner in healthcare, through transformative AI & data management solutions for disease screening and monitoring. Join our diverse team of entrepreneurs, developers, researchers, and commercial experts who are collectively shaping the future of healthcare.

We are looking for a meticulous and driven QRA Specialist to strengthen our quality and regulatory operations team. This role is ideal for a highly motivated professional with a background in SaMD / MDSW regulations (EU & US), who thrives in a collaborative, fast-paced environment. The QRA Specialist will contribute to regulatory strategies, maintain our QMS, and ensure compliance with international medical device regulations and standards.