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., warehouses).
Ensure batch follow-up and traceability for products on the market, batch release.
Manage customer complaints, product recalls, field safety corrective actions, and vigilance activities in relation with UM Integral.
Manage deviations, CAPAs, and change control.
Oversee post-marketing surveillance (e.g., local literature monitoring, competitor adverse events).




Ensure quality compliance in sourcing and supply of non-group or third-party products.
Complete and report Key Performance Indicators (KPIs) related to Quality Assurance.
Número de vacantes: 1
Modalidad de trabajo: Híbrido (25%)
"
**Requisitos**
Degree in pharmacy
Minimum of 3-5 years of experience in a similar role
Must have experience in healthcare technology or pharma
Fluent in English and Spanish, both verbal and written. Other languages in the region (Italian, Portuguese) will be a plus
Knowledge of the ISO 13485, GMP, and MDD93/42 EEC, MMD 2007/47, Recast Quality Systems MDR 2017/745
Knowledge of the regulatory requirements for Medical Devices (priority), drugs
Knowledge of law EEC 2001/83 for pharmaceutical products
Mastery in MS Office tools (Excel and PowerPoint in particular)
Willingness to travel
KEY COMPETENCIES:
Planning and organization skills
Rigorous, attention to detail
Good communication skills, both verbal and written
Oriented to results
Ability to work with people from diverse backgrounds
Estudios mínimos
Licenciado en Ciencias de la Salud
**Idiomas**:
Inglés nível Alto.
Experiência mínima
4 años
Disponibilidad para viajar
El 40% del tiempo laboral

📌 International Quality & Regulatory Mgr (Barcelona)
🏢 Importante Empresa Del Sector
📍 Barcelona