We are currently seeking a Quality/Regulatory Specialist to join a dynamic, innovative organization with a strong reputation in medical technologies and devices for hospitals in Belgium.

Your Responsibilities:

• Maintain, implement, and enhance the Quality Management System (QMS) in compliance with ISO 13485 standards.
• Develop and update processes, policies, and work instructions with a process-oriented approach.
• Monitor QMS performance through KPIs, complaints management, supplier evaluations, CAPAs, and audits (internal and external).
• Drive continuous improvement actions by challenging the status quo and collaborating with stakeholders.
• Promote QA/RA awareness and train colleagues on regulatory compliance and quality mindset.
• Ensure compliance with applicable regulations, including MDR, IVDR, Biocides, and other relevant legislation.
• Manage quality-related correspondence and ensure timely follow-up.
• Translate business strategy into operational processes while ensuring regulatory compliance and alignment with stakeholder needs.
• Monitor and implement regulatory updates, ensuring all processes remain compliant.
• Collaborate with cross-functional teams to optimize processes and enhance efficiency.

Your Skills and Profile:

• Strong, assertive communicator with excellent diplomacy skills.
• Proactive mindset with a pragmatic, solution-oriented approach.
• Independent and organized with strong analytical and problem-solving abilities.
• Customer-focused and stress-resistant, with the ability to adapt to changing priorities.
• Proven team player who takes ownership and initiative.
• Experienced in ISO 13485. A first experience in QA is a must.
• Proficient in Microsoft Office tools (Word, Excel, Outlook, etc.).
• Familiarity with medical device legislation (MDR) is a plus.
• Trilingual: Fluent in Dutch, French, and English (spoken and written).

Ready to make an impact? Submit your application today!