Beschreibung

In this role, you will lead the Quality Management System to ensure compliance with ISO 13485 and regulatory standards. Your day-to-day responsibilities will include training staff, managing audits, and collaborating with teams to enhance quality and regulatory practices.

Anforderungen

• •Higher education degree (PhD, BA, MA)
• •Two years of experience managing quality management systems
• •Strong communication skills (EN/DE)
• •Proven experience in Quality Management within medical device industry, preferably in SaMD/AIaMD
• •Strong knowledge of QMS, CAPA, Management Reviews, and risk management (esp. ISO 14971)
• •Familiarity with AI/ML validation, software development workflows, and lifecycle management
• •Experience with regulatory submissions and audits (MDR, IVDR, MDSAP, FDA SaMD Guidance, IMDRF)
• •Certified Auditor for ISO 13485 (additional ISO 27001, ISO 9001 as a plus)
• •Experience in cybersecurity, data privacy (GDPR, HIPAA, IEC 81001, IEC 27001)
• •Understanding of AI/ML-specific regulatory requirements (e.g., GMLP, EU AI Act)
• •Prior experience in startup or scale-up environments
• •Fluent in German (minimum B2-level)

Aufgaben

• •Maintain and improve the Quality Management System (QMS)
• •Ensure compliance with ISO 13485 and regulatory requirements
• •Coordinate updates to key SOPs and processes
• •Support internal audits and data privacy initiatives
• •Act as the person responsible for regulatory compliance under MDR
• •Provide guidance on quality and compliance issues
• •Train staff on QMS processes and regulatory best practices
• •Prepare for management reviews and assist with SOP management
• •Manage internal and external audits for compliance
• •Drive continuous improvement initiatives
• •Support IT security and related employee training
• •Advise and support stakeholders on quality and regulatory matters
• •Collaborate with cross-functional teams for compliance throughout the product lifecycle

Tools & Technologien

Benefits