Head of Product Compliance (f/m/d)

We see the potential inside everything and everyone. Starting with you. Orbem uses AI to industrialize MRI, delivering non-invasive insight into everything from fruits to eggs to the human body. We are transforming what is becoming the world's largest biological dataset into actionable intelligence to reduce waste, increase quality, and accelerate the shift toward a more sustainable and healthier future. Headquartered and founded in Munich, Germany, with an office now in Houston, Texas, our world-class team is scaling inside-out technology to transform how humanity sees and understands biological matter. Help us see what's possible. Join us. Your Role Reporting directly to the Senior Director of Product, you will drive product quality management and regulatory compliance for Orbem’s cutting-edge systems across the EU, US, and other upcoming markets. You will serve as the strategic bridge connecting complex hardware, software, and AI capabilities with international safety and industry standards. Leading and scaling the product compliance team, you will ensure our products meet global market standards and internal quality requirements fast. Your Day-to-Day Enable Global Product Impact: Own compliance roadmaps for international market access, securing NRTL approvals and achieving CE marking through the Machinery Regulation and EMC Directive. Lead and Scale the Team: Mentor and grow the product compliance team, fostering a culture of continuous learning, fast delivery, and strong ownership. Cross-Functional Collaboration: Partner closely with product development disciplines, Field Operations, Supply Chain, Procurement, and Legal experts to embed compliance and quality management seamlessly into our product lifecycle. Close the Conformity Loop: Own the path from field and production nonconformances through root-cause analysis and CAPA into updated risk assessments, technical files, and design changes — so what we learn on site changes what we build. Stakeholder Enablement: Translate complex regulatory frameworks into clear guidance, facilitating alignment and smooth execution across multidisciplinary teams. Agile Framework Optimization: Maintain structured compliance guidelines while adapting processes to support the fluid pace of a fast-growing scaleup environment. Champion system validation processes to ensure product reliability. Own Regulated Product Documentation: Take accountability for operator, installation, and maintenance manuals, safety markings, and translations as conformity deliverables in their own right, leading the technical writers who produce them. Your Experience and Skills You have 10 + years experience in compliance and quality management and proven experience in a leadership role, ideally within an agile scale-up or high-growth tech environment. Experience overseeing complex systems that combine hardware, software, and AI, ideally involving special machinery or automation equipment. You have run nonconformance and CAPA processes for complex electromechanical products, with hands-on root-cause practice (8D, FMEA, fault tree or equivalent) and a track record of field failures actually changing designs. Broad knowledge of international product compliance frameworks, specifically UL508A and NFPA79 approvals, and CE marking under the Machinery Regulation and EMC Directive. You have defined quality and compliance requirements in stage-gate processes, and built Design for Compliance, and Design for Quality principles in the product development process. Track record of building, mentoring, and scaling technical teams. Strong cross-functional communication and stakeholder management skills with a collaborative leadership mindset. You are comfortable defining a common framework for acceptance criteria and verification evidence, including factory and site acceptance testing, calibration, and measurement traceability.   What Makes You Stand Out Direct domain experienc