Job Description
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 ...