👋 About Us

Quadrivia is the health technology company behind Qu, a comprehensive, controllable, and customizable assistant AI built by clinicians, for clinicians. Addressing the urgent shortage of healthcare professionals, Qu provides real-time, personal, and reliable support for clinical tasks across the care continuum. Designed for providers, payers, and pharmaceutical companies, Qu is easy to customize and integrates seamlessly into workflows, delivering precise assistance across the care spectrum.

💼 About the Role

This is a full-time role for a Quality and Regulatory Compliance Manager, with offices in Barcelona and London. The Quality and Regulatory Compliance Manager will be responsible for ensuring that the organization adheres to all relevant global regulatory requirements in data privacy and medical device regulation, among other regional compliance obligations. Day-to-day tasks will include monitoring and reviewing compliance issues, implementing and maintaining policies and procedures, managing regulatory affairs, and conducting detailed analyses. The role involves collaborating closely with our product team to maintain our product compliant while not compromising development speed. It also implies working with various departments such as finance to ensure the company’s operations comply with applicable laws and regulations.

🔥 Key Responsibilities

• Responsible for managing the Quality & Regulatory affairs (QA&RA)
• Implement the regulatory strategy to develop, manufacture, and distribute the company’s medical devices.
• Budget management of the QA&RA Department
• Communicate vigilance actions (incident reports, FSCA and FSN) to the Regulatory Authorities and theNotified Body.
• Actively collaborate in the audits and internal and external inspections of the Competent Authorities, the Notified Body, customers and to subcontracted manufacturers.
• Participate in the management of change control processes.
• Implementation, monitoring, and maintenance of the Quality Management System according to the current certifications defined by the Company's Management.
• Ensure the application, compliance, and constant improvement of the company's quality assurance system, guaranteeing compliance with current quality standards throughout the product’s life cycle (FDA regulation, ISO 13485, and any other legislation applicable to the geographical area where the company develops its activities).
• Review the technical documentation related to validations and manufacturing processes and participate in the release of the finished product.
• Lead internal and external audits and inspections of Health Authorities, clients, or subcontracted manufacturers.
• Evaluate supplier reports and follow up on the necessary preventive and corrective actions.
• Provide ongoing training to all staff on Quality issues and ensure its application and compliance.
• Manage the PMS /PMCF system:
• Responsible for the Post-Market Surveillance System
• Ensure compliance with the Post-Market Monitoring System
• Manage and coordinate Adverse Incidents and Field Safety Corrective Actions (FSCA).
• Report Adverse Incidents and FSCA to Competent Authorities and the Notified Body.
• Ultimate responsible for the Quality Controls activities as team manager.
• Participate in the management of the system for recording and monitoring deviations, change control, claims, and corrective and preventive actions, prepare their documentation and research, and carry out their follow-up.
• Participate in the Risk management and Design Control processes.
• Participate in the design of label content
• Maintain an up-to-date knowledge of published regulations within the scope of medical devices.
• Inform the Management of any risk situation for the company related to the development, manufacture and marketing of the medical devices.
• Represent the company before the Competent Authorities and the Notified Body.
• Keep the technical documentation updated in compliance with national, European, and US legislation and any applicable jurisdictions.

😊 About You

• Bachelor’s degree in science, life sciences or engineering.
• Specific training in Regulatory Affairs and Quality Assurance.
• Minimum 5 years of QA&RA leadership experience in the scope of medical devices.
• Spoken and written English with professional competence.
• Person used to work as a team, methodical and organized.
• At least 5 years of experience as an internal auditor.