Quality & Regulatory Affairs

We are looking for a Quality & Regulatory Affairs Specialist to support the local operations of a global medical device organisation. This role sits at the intersection of Quality Assurance, Regulatory Affairs, and Post‐Market activities, ensuring compliance with national and European medical device requirements.

Key Responsibilities

• Manage product quality complaints, including assessment, documentation, coordination of returns, and follow‐up with internal teams.
• Support Field Safety Corrective Actions (FSCA), including handling Field Safety Notices and reconciliation activities.
• Maintain and improve the local Quality Management System in alignment with ISO 13485 and internal procedures.
• Drive and support CAPA, deviations, issue evaluations, and continuous improvement initiatives.
• Assist with regulatory submissions, product registrations, notifications, and interactions with competent authorities.
• Participate ...