Junior Quality & Regulatory Assistant

About the role

We are looking for a detail‑oriented Junior Quality & Regulatory Assistant to join our team in Berchem (Antwerp). This full‑time, on‑site position offers hands‑on experience in regulatory affairs and quality management within a fast‑growing medical‑device company.

Key responsibilities

• Draft and maintain product submission files for CE, FDA and other market approvals.
• Communicate with regulatory agencies such as the FDA and European notified bodies.
• Participate in internal and external quality audits.
• Support distributors with local registration and regulatory queries.
• Maintain the Quality Management System in compliance with ISO 13485.
• Prepare and submit reimbursement documentation.

Required profile

• Bachelor’s degree or higher.
• Ability to work independently and take initiative.
• Detail‑oriented and well‑organized.
• Eager to learn and develop in a regulatory/quality environment.
• Fluent in spoken and written English.

Required skills

• CE marking procedures.
• FDA regulatory processes.
• ISO 13485 compliance.
• Product submission documentation.
• Reimbursement file preparation.

What we offer

• Attractive salary.
• Full‑time permanent contract.
• Laptop and necessary tools.
• On‑the‑job training (internal and external).
• International, supportive team environment.