Quality Assurance and Regulatory Affairs Specialist supporting EMEA commercial operations for medical device compliance. Responsible for maintaining ISO ***** standards, regulatory submissions, complaint handling, and field actions across assigned regions.
Responsibilities
Support implementation and maintenance of local Quality Management System per international standards
Manage product registrations, notifications, renewals, and regulatory clearances in assigned markets
Handle complaint submissions, coordinate product returns, and conduct investigations
Serve as liaison for field actions, recalls, and regional stakeholder coordination
Drive corrective and preventive actions and participate in management review meetings
Requirements
Knowledge of ISO ***** and medical device regulatory frameworks
Experience with European Medical Device Regulation (EU) ********
Familiarity with quality management systems and CAPA processes
Regulatory documentation and submission experience
Complaint handling and product surveillance experience
Fluency in English; local language proficiency beneficial
Compensation:
€32,****** minimum annual salary, plus variable pay and benefits
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