QA Compliance Expert – Medical Devices

About the role

Join Novartis as a QA Compliance Expert and play a pivotal role in safeguarding patient safety and product quality across the Medical Devices portfolio. Based in Ljubljana, you will work in a fast‑moving environment, collaborating with cross‑functional teams to ensure that all quality and regulatory activities meet the highest standards.

Key responsibilities

• Ensure all quality activities comply with current good practices and data integrity requirements.
• Review, approve and release documentation, change controls, product transfers and quality records for medical devices.
• Coordinate complaint handling, investigations, corrective and preventive actions (CAPA).
• Support inspections, assessments and regulatory evaluations, maintaining readiness for audits.
• Review and approve regulatory documentation required for specific markets.
• Monitor quality indicators, identify improvement opportunities and drive operational excellence.
• Collaborate with multidisciplinary teams to implement consistent quality and compliance requirements.
• Act as a trusted quality expert, promoting a culture of compliance, responsibility and quality.

Required profile

• University degree in pharmaceutical, biological, chemical, microbiological or a related natural science field.
• Minimum three years of experience in manufacturing, development, quality or another regulated environment.
• Proficient in English; Slovenian language skills are an advantage.
• High level of initiative, responsibility and ability to organise work independently.
• Strong capability to manage multiple tasks simultaneously in a dynamic setting.
• Commitment to continuous learning and quality improvement.

Required skills