Data & Quality Manager

Role Overview

As Data & Quality Manager, you will play a key role in the operationalization and day-to-day ownership of Nuclivision’s Quality Management System (QMS) and Information Security Management System (ISMS). You will support and progressively take responsibility for ongoing and planned certifications (including ISO 13485 and ISO 27001), regulatory compliance (including CE and FDA product clearances), and audit readiness.

In addition, you will support cross-functional teams with operational and administrative tasks that ensure the company runs efficiently, while maintaining clear priorities around quality, regulatory, and information security activities.

This role offers real decision-making responsibility and a clear growth path toward a future QARA Manager position.

Responsibilities

• Maintain and operationalize the QMS and ISMS, ensuring alignment with applicable standards and regulations.
• Support and coordinate certification activities (e.g. ISO 13485, ISO 27001), audits, and follow-up actions.
• Manage controlled documentation, data analyis, records, and change processes.
• Support risk management, quality events handling, and continuous improvement initiatives.
• Act as a point of contact for internal stakeholders on quality, regulatory, and information security topics.
• Contribute to compliance across the product lifecycle, including R&D, clinical, and commercial activities.

Required Qualifications

• Bachelor’s or Master’s degree in a life sciences, engineering, biomedical, or related field.
• Initial experience (or strong interest) in quality assurance, regulatory affairs, or compliance in a MedTech or regulated environment.
• Strong organizational skills and attention to detail.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Clear written and verbal communication skills.
• Fluency in English.

Preferred Qualifications

• Exposure to medical device or cybersecurity regulations (e.g. ISO 13485, MDR, ISO 27001, FDA).
• Experience in a startup or scale-up environment.
• Interest in AI software, medical imaging, or nuclear medicine.
• Familiarity with documentation systems or compliance tooling.

What We Offer

• Competitive salary & real impact – Help bringing products to market safely and effectively, shaping the future of AI software in nuclear medicine.
• Plenty of ownership and a clear growth trajectory – Work side by side with the Operations and Product team shaping the quality and regulatory strategy of Nuclivision.
• Flexible perks – Laptop, phone subscription, expense reimbursements, and other perks adapted to your contract.
• Team that learns & has fun – Expect teambuildings, after-work drinks, and trainings to grow your skills along the way.

Location: Nuclivision is a startup company headquartered in Ghent, Belgium. We offer remote working options.

How to Apply

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