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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 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

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.