IT Medical & Regulatory Affairs Manager (m/f/d)

Focus: Development Medical Devices, QMS & MDR Compliance / ISO Certification

Black Digits creates the technological foundation for digital freedom of choice in Europe. As an IT and digital division of the Schwarz Group, we develop and manage the IT infrastructures for the Lidl and Kaufland trade divisions as well as the Black Production and PreZero. At the same time, we act as an independent provider on the external market to support companies across Europe in their digital transformation. We bundle our core services in the areas of cloud, cyber security, data & AI, communication and workspace. You also contribute to the digital freedom of choice in Europe.

With us you work at the interface between agility and security: You benefit from the fast decision-making, enjoy real design spaces in your projects and build on the stable foundation of the Schwarz Group.

Your mission You accompany our medical devices over the entire life cycle and through all risk classes. Your focus is on the early stage of product idea, technical feasibility and documentation, while ensuring that our quality management system (QMS) meets the highest international standards. You are significantly involved in obtaining and maintaining ISO certifications and ensuring complete MDR compliance.

Innovation Guide & Classification: You will examine new product ideas from a medical perspective on their feasibility, define the purpose and classify our products precisely according to MDR. Full-Lifecycle Regulatory Management: You are responsible for the creation and maintenance of complete technical documentation for conformity assessment and accompany the process up to the successful CE marking. QMS & ISO certification: You control the construction, maintenance and continuous improvement of our quality management system according to ISO 13485 and accompany audits. Standards Compliance & Safety: You ensure that our development processes meet all requirements of IEC 62304 (software life cycle), IEC 62366 (usability) and ISO 14971 (risk management). Clinical evaluation & performance: You will set up clinical assessment reports as a foundation for the performance of our products and define the basic safety and performance requirements up to post-market surveillance. Privacy & Compliance: You act as a central interface for data protection issues in the medical context and ensure compliance with all relevant regulatory compliance policies. .