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The Position
Within the Quality and Regulatory Subchapter in the Business Integrity Knowledge Area of Roche Diagnostic Spain, and providing services to Roche Diabetes Care Spain, the Vigilance and Post Market Responsible will undertake the Local Safety Officer responsibilities, ensuring quality compliance with respect to Post Market Quality requirements and Regulations. This role contributes to the growth and sustainability of the company, customer satisfaction, and patient safety.
Your Key Responsibilities :
* Support all functions involved in Post Market Surveillance activities to ensure quality compliance with Post Market Quality requirements.
* Act as the contact person towards DIA Global Quality and Regulatory regarding complaint management, incident handling, and Field Safety Notices.
* Communicate timely to DIA Global Quality Management & Regulatory any significant changes in local regulations related to post-marketing surveillance of medical devices.
* Establish, monitor, and strengthen the setup of Case Management requirements as per Post Market Module and applicable GSPs, ensuring compliance and audit readiness.
* Train personnel involved in complaint management and incident identification; ensure third parties involved work under a contractually established responsibilities and roles, complying with local and Roche regulations.
* Implement and ensure the correct and timely implementation of Safety Board Notifications (SBN) and Quality Notifications (QN), maintaining audit-proof evidence for regulatory authorities. Implement instructions from Safety Boards in the Affiliate.
* Process Field Safety Corrective Actions (FSCA) received from manufacturers or established by Roche Diagnostics, S.L, in compliance with standards and regulations.
* Serve as a contact with local authorities regarding Field Safety Notices.
* Support compliance for Medical Software from the manufacturer role.
Who You Are :
* Bachelor's Degree in health sciences or related to manufacturing technologies of medical devices and in vitro diagnostics.
* Proficiency in Spanish and English.
* Background in IVD business and product technical knowledge.
* Knowledge of European and national legislation related to medical devices and in vitro diagnostics (distributor and manufacturer).
* At least 3 years of professional experience in Vigilance, Complaint Handling, Product Management in the health sector, preferably in the IVD industry.
Skills you will use at the role :
* Decision making
* Technical and business skills
* Teamwork and collaboration
* Achievement of results
* Feedback and coaching
* Change management
* Communication
* Problem solving
* Inspiration and influence
* Project management
Who we are : At Roche, more than 100,000 people across 100 countries are pushing the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.
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