QA/RA Officer – Quality & Regulatory Affairs

About the role

Join LaCAR, a fast‑growing European biotech company, as a QA/RA Officer. You will support the development, maintenance and continuous improvement of the Quality Management System while ensuring compliance with European and international regulatory requirements.

Key responsibilities

• Manage and update QMS processes, including documentation, records, non‑conformities, CAPA, data and risk analysis, change controls, regulatory watches, product registration and post‑market surveillance.
• Review manufacturing documentation and batch records and release batches.
• Prepare for and participate in external, internal and supplier audits.
• Take part in design review and validation meetings.
• Compile and maintain technical documentation.
• Ensure QMS processes meet applicable norms and regulatory requirements (ISO 13485, IVDR, etc.).
• Coordinate product registrations in the EU and other markets.
• Lead or contribute to QA/RA projects and engage internal and external stakeholders.

Required profile

• Master’s degree in chemistry, biochemistry, biology, biomedical sciences or a related field.
• Familiarity with ISO 13485 and IVDR; knowledge of MDSAP and FDA regulations is a plus.
• Reliable, motivated, organized, rigorous and able to work autonomously.
• Proactive problem‑solver with good team spirit.
• Advanced English (minimum B2) for daily professional communication.

Required skills

• ISO 13485
• IVDR
• MDSAP
• FDA regulations
• Quality Management System (QMS) implementation
• CAPA management
• Risk analysis
• Change control
• Product registration
• Post‑market surveillance
• Audit preparation
• Technical documentation

What we offer

• Dynamic, stimulating environment in the biotech sector.
• Structured role with varied tasks for skill development.
• Opportunity to join an innovative, fast‑growing company.
• Collaborative, international team with fun events.
• Flexible working hours and competitive salary package.
• Permanent contract (38 h/week) at a modern HQ overlooking the woods of Sart‑Tilman.
• Free fruits and snacks.