Chief Information Officer • Valencia
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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 PostMarket Specialist is responsible for undertaking the Local Safety Officer responsibilities ensuring 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.
* Establish, monitor and strengthen the set-up of Case Management requirements in the Affiliate as per Post Market Module and applicable GSPs to ensure compliance and audit-proof status.
* Ensure the training of personnel involved in complaint management and incident identification, ensuring third parties comply with local and Roche regulatory requirements.
* 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 regulatory authorities.
* Ensure that all Field Safety Corrective Actions (FSCA) received from manufacturers 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.
* 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
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back 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. Roche is an Equal Opportunity Employer.
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