International Quality & Regulatory Mgr

In alignment with corporate and regional guidelines, define, implement, and continuously improve the Quality, Regulatory Affairs, and Compliance systems and procedures for Spain and Portugal, as well as provide support to Italy in coordination with the local responsible person. He/she will hold technical Director Responsibility for Spain.
**MAIN RESPONSIBILITIES**:
Quality Management System ´
Define, implement, and maintain the local Quality Management System (QMS)
Obtain and maintain ISO13485 certification by Notified Body for Spain activities of the commercial affiliate.
Maintain and continuously improve quality documentation and procedures.
Organize and deliver regular training on Quality Assurance topics to all relevant employees.
Manage internal audits, corporate self-assessments, and inspections by Health Authorities, and audits from Notified Body (ISO13485).
Monitor (audit) and manage (qualification) distributors and third-party logistics providers (e.g.,...

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