Unora

Compliance

• Maintain and continuously improve the quality management system in accordance with ISO 13485, the MDR, and MDSAP
• Promote awareness of quality-related requirements throughout the organization
• Conduct management reviews and training sessions
• Monitor system effectiveness and manage CAPA activities
• Apply and oversee risk management processes
• Qualify and monitor suppliers, including audits, and conduct regulatory assessments of supplier changes
• Act as deputy for the Clinical Affairs Manager in clinical documentation and PMCF activities
• Report on quality matters to management and regulatory authorities
• Plan and conduct internal and external audits in accordance with ISO 13485, the MDR, and MDSAP
• Manage CAPAs and deviations within the team and in collaboration with relevant departments
• Systematically monitor production and quality assurance processes
• Ensure the conformity and market authorization of medical devices in the EU, Switzerland, the UK, and international markets
• Prepare, maintain, and update technical documentation, including UDI data, EUDAMED entries, and labeling
• Conduct regulatory assessments of changes within the change control process
• Monitor regulatory trends and derive necessary actions
• Provide regulatory approval for labels, IFUs, and claims

Explore Quality Management – Regulatory Affairs Manager at Unora. Review requirements and application details.