Position Summary : The Quality & Regulatory Manager is responsible for managing the QA / QC & RA of products and processes to ensure compliance with industry standards such as ISO 13485 and MDR (2017 / 745). Responsibilities include Quality Assurance (creating SOPs, training plans, measurement and calibration, non-conformance management, audits), Quality Control (incoming inspections, document verification), and Regulatory Affairs (product registration, health & safety compliance).
Please submit your application in English.
Responsibilities
1. Document Control : Create and update SOPs for DMT Spain, aligned with ISO 13485 and MDR standards.
2. Complaint & Non-conformance Management : Control and manage complaints from customers, suppliers, or internal sources, ensuring timely handling and proper documentation.
3. CAPA : Responsible for Corrective and Preventive Actions.
4. Calibration & Testing Equipment : Ensure tools are within parameters, properly calibrated, documented, and maintained. Develop budgets and suggest new tools.
5. Equipment & Material Repairs : Manage repair processes and associated costs.
6. Training Plan : Develop and oversee annual training for staff, collaborating with the Technical Service Manager Iberia.
7. Health & Safety : Maintain updated documentation, ensure field service engineers' dosimeters are sent monthly, schedule staff medical tests, and manage related documentation.
8. Regulatory : Register products in Spain and Portugal, gather technical specifications, and liaise with authorities for timely registration.
9. Continuous Improvement : Lead initiatives for ongoing improvement across DMT Spain.
10. Audits : Serve as responsible person for internal and external audits.
11. CSN Yearly Report : Compile information for the annual report to the Spanish nuclear authority for X-ray devices and provide certificates upon equipment installation or exchange.
12. Training for Regulatory Position : Train to assume the role of “Tecnico Responsable Garante de Producto Sanitario” within 1-2 years, per Spanish regulations.
13. Procedures & Forms : Create specific procedures and forms on the Cytrix platform for DMT Spain.
14. Babtec Implementation : Manage the deployment of Babtec software in DMT Spain.
15. Communication : Notify staff of changes in standards or laws affecting the business.
16. Management Review : Provide information for management review in accordance with ISO 13485.
Your profile
1. Higher degree with certifications in quality standards (ISO 13485, ISO 9001).
2. ISO 13485 Auditor certification is desirable.
3. Experience in Quality Management, Assurance, Control, and Regulatory affairs.
4. Experience with Medical Devices and quality systems.
5. Knowledge of the MedDev market and MDR (2017 / 745).
6. Process-oriented, leadership by example, team player.
7. ERP knowledge, proficiency in MS Office.
8. Fluent in Spanish, Catalan, and English (spoken and written).
About us
Dornier MedTech, headquartered near Munich, Germany, is a pioneer in urology medical devices and a subsidiary of Advanced MedTech. We are committed to innovation, patient safety, and product efficacy, setting standards in digital urology and supporting communities worldwide.
#J-18808-Ljbffr