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
* Document Control: Create and update SOPs for DMT Spain, aligned with ISO 13485 and MDR standards.
* Manage non-conformance complaints from customers and suppliers, ensuring timely and proper documentation.
* CAPA responsibility
* Calibration & Testing Equipment: Ensure tools are within parameters, properly calibrated, documented, and maintained. Prepare annual budgets and suggest new tools.
* Manage repair of equipment & materials, including cost management.
* Develop and implement the yearly staff training plan, ensuring documentation and adherence.
* Health & Safety: Maintain records, ensure dosimeters are sent monthly, schedule medical tests, and manage documentation.
* Regulatory: Register products in Spain and Portugal, collect information, create technical specifications, and liaise with authorities.
* Promote continuous improvement across DMT Spain.
* Internal and external audits management.
* Prepare and consolidate data for the CSN yearly report and manage certificate issuance for X-ray equipment.
* Perform validations as needed.
* Train to assume the “Técnico Responsable Garante de Producto Sanitario” position within 1-2 years.
* Create procedures and forms on the Cytrix platform for DMT Spain.
* Manage Babtec implementation.
* Communicate changes in standards or laws affecting the business.
* 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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