Your mission
Position Summary: The Quality & Regulatory Manager is responsible for managing QA/QC & RA of products and processes to ensure compliance with industry standards, 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. Manage non-conformance complaints from customers and suppliers, ensuring timely and proper documentation.
3. CAPA responsibility
4. Calibration & Testing Equipment: Ensure tools are within parameters, properly calibrated, documented, and maintained. Prepare annual budgets and suggest new tools.
5. Manage repair of equipment & materials, including cost management.
6. Develop and implement the yearly staff training plan, ensuring documentation and adherence.
7. Health & Safety: Maintain records, ensure dosimeters are sent monthly, schedule medical tests, and manage documentation.
8. Regulatory: Register products in Spain and Portugal, collect information, create technical specifications, and liaise with authorities.
9. Promote continuous improvement across DMT Spain.
10. Internal and external audits management.
11. Prepare and consolidate data for the CSN yearly report and manage certificate issuance for X-ray equipment.
12. Perform validations as needed.
13. Train to assume the “Técnico Responsable Garante de Producto Sanitario” position within 1-2 years.
14. Create procedures and forms on the Cytrix platform for DMT Spain.
15. Manage Babtec implementation.
16. Communicate changes in standards or laws affecting the business.
17. Provide management review information per ISO 13485.
Your profile
* Higher degree with certifications in ISO 13485 and ISO 9001.
* ISO 13485 Auditor certification is desirable.
* Postgraduate in Medical Devices is desirable.
* Experience in Quality Management, Assurance, Control, and Regulatory Affairs.
* Knowledge of Medical Devices market and MDR (2017/745).
* Process-oriented with problem-solving mindset.
* Leadership by example and team player.
* Learning attitude.
* SharePoint and ERP knowledge.
* Fluent in Spanish, Catalan, and English (spoken and written).
* Proficient in MS Office.
Why us?
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