Key Responsibilities:

1. Regulatory Affairs Management
- Compliance Verification: Conduct rigorous reviews of Technical Files from international manufacturers to ensure full alignment with MDR 2017/745 and valid CE marking requirements.
- Product Registration: Lead the end-to-end registration process in relevant databases and act as the primary point of contact for AEMPS to secure necessary product authorizations.
- Labeling & IFU Oversight: Supervise all product labeling and Instructions for Use (IFU) to ensure strict compliance with Spanish language requirements and legal mandates (e.g., batch numbers, expiry dates, and standardized symbols).
- Regulatory Intelligence: Proactively monitor updates in EU and Spanish medical device regulations, providing timely impact assessments and strategic recommendations to senior management.

2. Quality Management System (QMS) Oversight
- ISO 13485 Implementation: Design, document, and execute a robust Quality Management System in strict accordance with ISO 13485 standards.
- Supplier Qualification:



Perform technical evaluations and audits of manufacturers and suppliers to ensure they meet stringent medical-grade quality and safety standards.
- Incoming Quality Control (IQC): Oversee technical inspections of incoming goods, ensuring packaging integrity, storage condition compliance, and physical alignment with technical documentation.
- Document Control: Establish and maintain a rigorous archival system for all technical files, certifications, and inspection reports to ensure data integrity and traceability.

3. Post-Market Surveillance, Traceability & Compliance

· Full Traceability Management: Implement and manage a comprehensive traceability system to track products from arrival (Lot/Batch Number) through to final delivery to the end-user (clinics/dentists).

· Complaint Handling & Investigation: Manage the end-to-end process for customer complaints, including technical investigation, root cause analysis, and reporting to m

📌 Regulatory Affairs (Alcobendas)
🏢 Medilnt
📍 Alcobendas