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 manufacturers and regulatory bodies when required.
· Recall & Risk Management: Develop and execute operational protocols for rapid product recalls in the event of technical defects or mandatory orders from health authorities.
· Post-Market Surveillance (PMS): Drive the collection and analysis of real-world product performance data to generate periodic reports and ensure continuous product safety.
· Authority Liaison & Audit Readiness: Serve as the technical lead and official liaison during inspections by AEMPS and health authorities in Madrid; maintain constant “Audit Readiness” for both scheduled and unannounced inspections.
Qualifications:
· Strong foundation in regulatory affairs for medical devices, including practical experience with EU MDR, CE marking, and product registration processes.
· Quality management skills, such as implementing and maintaining QMS (e.g., ISO 13485), managing audits, CAPA, and document control.
· Analytical and organizational skills, including the ability to interpret regulations, assess compliance risks, and manage multiple projects and deadlines.
· Communication and collaboration skills, with the ability to work effectively with international manufacturers, internal teams, and regulatory bodies.
· Relevant academic background, such as a degree in biomedical engineering, pharmacy, life sciences, or a related field.
· Proficiency in Spanish and English, both written and spoken, for regulatory correspondence and technical documentation.
· Previous experience in regulatory affairs and/or quality assurance within the medical device or dental device sector is highly beneficial.
· Detail-oriented mindset, commitment to ethical practices, and readiness to work on-site in Madrid in a structured, compliance-driven environment.
Job Type: Part-time
Pay: From 800.00€ per month
Work Location: In person
