MCM-2506-231
RESPONSIBLE PERSON - MEDICAL DEVICES
BARCELONA O MADRID

Mission:

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 Responsible Person 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 Global.
• 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.

Regulatory Affairs

• Maintain up-to-date knowledge of local regulations for medical devices and pharmaceutical products.
• Manage local regulatory files and ensure conformity of marketed products in relation with Health Authorities.
• Monitor regulatory changes and inform UM Global QA/RA/compliance with local impact assessments.
• Support Business Development activities by analyzing local regulatory requirements in export countries and coordinating submissions with partners.
• Contribute to the preparation and renewal of regulatory filings, both locally and in supported countries.
• Validate and translate packaging and promotional elements.

Regional Support

• Collaborate with the Italian team to ensure alignment and provide operational support when needed.
• Share best practices across the NORMED region to ensure consistency and continuous improvement.
• Maintain the link and communication with UM Global department.

Requirements:

• 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

Detalles / Details