Head of Product Compliance (f/m/d)

Description

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.

Responsibilities

• 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 experience with industrial automation systems in the food processing or agricultural sectors.
• Academic background in Electrical Engineering, Mechanical Engineering, or a related technical discipline.
• Fit to Our Values
• We Own Every Challenge: we enjoy complexity and thrive under uncertainty.
• We Strive for Better: we seize any opportunity for growth and challenge the status quo. We are constantly learning and improving.
• We Imagine New Frontiers: we think beyond “doable” and “reasonable”. We design a sustainable and healthy future together.

Benefits

• International Environment:
• Join a team with 40+ nationalities across 5 continents, all driven by a shared purpose: shedding light on the world’s toughest challenges.
• Comprehensive Benefits:
• Stock Options: Share in Orbem’s success.
• Relocation Support: Seamless support for your move to Germany.
• Learning & Development: €1,750 annual budget for personal growth.
• Fitness Membership: Access to Urban Sports Club or Wellpass.
• Childcare Reimbursement: Support for Kita/Kindergarten fees.
• Deutschland Ticket: Monthly subsidy towards public transportation costs.
• Work-Life Integration:
• Flexible Hours & Home Office: Work when and where it suits you.
• WFH Perks: Get €185 to upgrade your home office + an external monitor on us!
• 30 Days Paid Leave: Plenty of time to recharge.
• Personal Leave: Flexibility for life’s important moments.
• Work From Anywhere: Experience new cultures and environments for up to 60 days per year.
• Make a Difference:
• Join an ambitious, fast-growing team working on breakthrough technology. In our scale-up environment, you'll have the freedom to lead your projects and make an impact. We provide a platform for you to explore, innovate, and define your vision for the future. At Orbem, we're committed to helping you discover your strengths, and while we aim to teach you, we also want to learn from you.
• Your Team:
• You'll become part of our diverse and international team. Learn more about the team members, their work, and challenges here: https://orbem.ai/company/
• At Orbem, we're committed to building a smart, diverse team, and we recognize that self-doubt can prevent talented individuals from applying. If you feel you don't meet every requirement, we'd love to hear from you anyway!