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Quality & Regulatory Systems Manager

UV Medico
Åbyhøj

About UV Medico

UV Medico pioneers Far-UVC decontamination—defining the next standard in safe, continuous, chemical-free air and surface hygiene. We develop advanced light-based solutions for professional and clinical environments where safety is non-negotiable, performance must be proven, and documentation is mandatory. Our systems operate in high-risk settings and are engineered to comply with rigorous regulatory, quality, and environmental frameworks.

As we expand internationally and advance into hospital-grade applications, we are reinforcing our regulatory and quality infrastructure to meet FDA requirements and align with global standards. This role is integral to that transformation.

The Role

We are looking for a hands-on Quality & Regulatory Systems Manager to build, operate, and enforce UV Medico’s regulatory and quality foundation. This role owns FDA readiness, the Integrated Management System (ISO 9001, ISO 13485, ISO 14001), and operational quality control. It is an execution role, focused on making compliance work in practice—embedded in product development, manufacturing, and daily operations.

Key Responsibilities

  • Establish and maintain FDA-aligned quality and regulatory processes across the product lifecycle
  • Own and continuously improve the Integrated Management System covering ISO 9001, ISO 13485, and ISO 14001
  • Implement and maintain design control, technical documentation, and change management processes
  • Drive quality planning, risk management, and traceability from development through production
  • Lead design transfer quality activities from R&D to manufacturing
  • Define and operate QC processes, including incoming inspection, in-process controls, and product release
  • Manage nonconformances, deviations, CAPAs, and root-cause investigations
  • Prepare for and support regulatory inspections, certification audits, and customer audits
  • Work closely with R&D, manufacturing, suppliers, and external partners to ensure compliance is applied, not theoretical

Your Profile

  • 5+ years of hands-on experience in quality and regulatory roles for regulated or safety-critical products
  • Strong practical experience implementing and running ISO 9001 and ISO 13485 systems (ISO 14001 experience is a plus)
  • Solid understanding of FDA quality system requirements and audit expectations
  • Proven experience with QC, CAPA, change control, and audit readiness
  • Technical or engineering background
  • Structured, detail-oriented, and highly execution-focused
  • Comfortable taking ownership and driving compliance across the organization

What We Offer

  • A key role with direct ownership of quality and regulatory systems, with real influence on structure, compliance, and execution
  • The opportunity to shape and scale regulatory and quality infrastructure aligned with FDA expectations and global standards
  • A position within a dynamic, international team driven by continuous innovation, ongoing learning, and both personal and professional development

You will be working at our headquarters in Aarhus, Denmark.

UV Medico has a non-smoking policy.

We look forward to hearing from you!

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