Head of Product Compliance (f/m/d)
Core
Drive product quality management and regulatory compliance for Orbem's AI-powered MRI systems across EU, US, and global markets, serving as the strategic bridge between hardware/software/AI capabilities and international safety standards.
Role type
Senior leadership product compliance head (hardware/software/AI systems)
Builds
Globally compliant industrial automation systems (MRI for biological matter analysis)
Domain
Industrial automation / AI / Food processing & agriculture
Deliverable
production ML models
Required skills
Product compliance strategy, team leadership & scaling, root-cause analysis (8D, FMEA), international regulatory frameworks (CE, Machinery Regulation, EMC, UL508A, NFPA79), Design for Compliance, cross-functional stakeholder management
Preferred skills
Domain experience in industrial automation for food/agriculture, Electrical or Mechanical Engineering background
Technologies
MRI systems, AI, electromechanical automation equipment
Responsibilities
Own compliance roadmaps for international market access (NRTL, CE marking), mentor and scale the product compliance team, partner with product development and supply chain to embed compliance, manage nonconformance and CAPA processes, translate regulatory frameworks into team guidance, define acceptance criteria and verification evidence, lead technical writers for regulated documentation
Seniority
Senior, hands-on IC with leadership scope
