Head of Product Compliance (f/m/d)

present of AI

München

On-site

EUR 120,000 - 180,000

Full time

11 days ago

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Job summary

Orbem is seeking a Head of Product Compliance to lead the development and maintenance of quality management systems and regulatory strategies for its MRI hardware and AI products. This role sits at the intersection of hardware, software, and AI ethics, ensuring safety, quality, and regulatory readiness as Orbem scales globally.

The ideal candidate will have deep knowledge of EU and US medical device and machinery regulations, experience managing audits and submissions, and the ability to

Qualifications

  • Experience leading quality management systems for hardware and software products.
  • Proven track record with EU and US regulatory submissions.
  • Ability to translate technical details into compliant documentation.
  • Experience guiding cross-functional teams through certification processes.
  • Audits management experience.

Responsibilities

  • Lead development and maintenance of quality management systems.
  • Develop regulatory strategies for hardware and software products.
  • Translate technical details into compliant documentation.
  • Guide teams through certification and regulatory submissions.
  • Manage audits and regulatory submissions.

Skills

Regulatory compliance
Audits
Regulatory submissions
Quality management systems
EU regulations
US regulations

Job description

A Head of Product Compliance typically leads the development and maintenance of quality management systems and regulatory strategies for complex hardware and software products. A strong candidate brings deep knowledge of EU and US regulations for medical devices or machinery, plus experience managing audits and submissions. For a company like Orbem, which builds MRI hardware and AI for food and agriculture, the role likely requires translating technical details into compliant documentation and guiding teams through certification.

How it fits the AI era

AI changes compliance work by automating document review, tracking regulatory changes, and flagging risks in product data. The human side remains essential for interpreting rules, making judgment calls, and building trust with regulators. This role sits at that intersection, ensuring AI driven products meet safety and quality standards without slowing innovation.

How it builds AI experience

Working at Orbem would give hands on experience with AI systems that inspect eggs and produce, including how to validate algorithms and manage data integrity for regulatory submissions. Building this experience could involve learning about AI risk frameworks, such as the EU AI Act, and applying them to real hardware. It is a chance to shape compliance for AI in agriculture, a field still forming its rules.

Worth showing
  • EU and US compliance
  • Quality management systems
  • Regulatory submissions
  • Audit leadership

This is our own read, written from the employer's posting and the company's Spotlight. The employer's posting is the source of truth for the role.

About Orbem

Orbem develops high-throughput magnetic resonance imaging hardware and artificial intelligence algorithms that non-invasively inspect poultry eggs and agricultural produce.

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