Roche favorise la diversité, l’équité et l’inclusion, reflétant ainsi les communautés auxquelles nous nous adressons. Dans le domaine de la santé à l’échelle mondiale, la diversité est un ingrédient essentiel de la réussite. Nous sommes convaincus que l’inclusion est primordiale pour comprendre les différents besoins des personnes en matière de santé. Ensemble, nous célébrons nos différences et notre passion commune pour des soins de qualité exceptionnelle. Rejoignez Roche, une société où chaque voix compte.
La 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 PostMarket Specialist is responsible to undertake the Local Safety Officer responsibilities ensuring the quality compliance with respect to Post Market Quality requirements and Regulations contributing to the growth and sustainability of the company, customer satisfaction, and patient safety.
Your Key Responsibilities:
* Provide support to all functions involved in Post Market Surveillance activities to ensure quality compliance of the Affiliate with respect to Post Market Quality requirements.
* Act as a contact person towards DIA Global Quality and Regulatory regarding complaint management, incident handling and Field Safety Notices.
* Timely communication to DIA Global Quality Management & Regulatory of any significant changes in local regulations related to post-marketing surveillance of medical devices.
* To Establish, Monitors and Strengthen the set-up of Case Management requirements in the Affiliate as per Post Market Module and applicable GSPs and to ensure that the affiliate is compliant and audit-proof with respect to those.
* Ensure the training of personnel involved in complaint management and possible incident identification and ensure that third parties involved in complaint management work under a contractually established allocation of responsibilities and roles and comply with local and Roche regulatory requirements.
* To implement and assure the timely and correct implementation of Safety Board Notifications (SBN) and Quality Notifications (QN) and audit-proof archiving of the corresponding evidence for the regulatory authorities. Ensure the implementation of instructions from the Safety Boards in the Affiliate.
* Ensure that all Field Safety Corrective Actions (FSCA) received from manufacturers (or established by Roche Diagnostics, S.L for medical software) are processed promptly and in compliance with applicable internal standards and regulations.
* Act as a contact person with local authorities regarding Field Safety Notices.
* Support compliance for Medical Software from manufacturer role.
Who You Are:
* Bachelor's Degree in health sciences or related to manufacturing technologies of medical devices and in vitro diagnostics is required.
* High level of Spanish and English.
* IVD business and product technical background
* Knowledge of European and national legislation related to medical devices and in vitro diagnostics (distributor and manufacturer)
* Desired professional experience of at least 3 years in the fields of Vigilance, Complaint Handling, Product Management, in the health sector (preferably in the IVD industry).
* Location: Sant Cugat, Barcelona.
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
Qui nous sommes
Roche, c’est 100,000 personnes à travers 100 pays qui repoussent quotidiennement les frontières de la santé pour apporter de nouvelles solutions aux patients. Notre succès commun est basé sur l’innovation, la curiosité et la diversité.
Roche est un employeur offrant l'équité en matière d'emploi.
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