Interpret and implement regulatory frameworks (e.g., MDR, ISO 13485 for Software-as-a-Medical-Device) within the company, Translate regulatory requirements into technical tickets for developers (e.g., in Jira), Create and maintain high-quality documentation: SOPs, policies, audit materials, labeling documents, Prepare and support internal and external audits and certification processes, Work closely with product, QA, engineering, and external partners to ensure compliance throughout the product lifecycle, Stay up-to-date on SaMD regulations, standards, and compliance best practices, Drive improvements in compliance awareness and implementation across the company, Travel to Berlin is required at least every 2 months
