Naima OMARI

– Risk Management (ISO 14971 - DM, IVD, SAMD) – Led and coordinated cross-functional teams (Regulatory, Clinical, Quality, R&D, Operations) to manage clinical and operational risks throughout the medical device lifecycle. – Facilitated risk workshops to align clinical risks (clinical evidence, usability, PMCF, benefit-risk) with operational risks (manufacturing, process changes, suppliers, post-market). – Acted as a bridge between clinical, regulatory and operational stakeholders, ensuring consistent risk identification, evaluation and mitigation strategies. – Supervised and guided teams in the implementation of risk control measures, verification of effectiveness, and integration into RMF, CER, PMS and change management processes. – Supported decision-making at management level by structuring risk-based discussions and translating regulatory conclusions into operational actions. – Quality Management Systems & Audits (ISO 13485) – Designed, implemented and restructured ISO 13485 QMS for medical device manufacturers. – Achieved ISO 13485 certification for multiple clients. – Led Management Reviews, KPI monitoring, process reviews, CAPA and vigilance systems. – Conducted internal and supplier audits and supported external audits – Batch Release – Delivered team training and quality culture deployment. – Acted as AFNOR External Auditor ISO 13485. – IVDR & MDR Technical Documentation & Performance Evaluation – Updated and remediated 50+ IVDR Technical Files (Class A-D). – Reviewed performance evaluation reports and analytical validation data. – Ensured Essential Requirements / GSPR mapping and alignment with IVDR 2017/746 – Led, authored and remediated complete Technical Documentation in compliance with MDR 2017/745 and IVDR 2017/746, covering Class I to III medical devices, SaMD and IVD (Class A to D). – Structured and maintained Annex II & Annex III documentation, ensuring consistency, traceability and audit readiness across the entire product lifecycle. – Prepared and supported Technical Documentation submissions to Notified Bodies (BSI, TÜV, AFNOR). – Managed responses to technical questions, non-conformities and remediation actions, including restructuring of documentation following audits or reviews – Regulatory Affairs & CE Marking (MDR / IVDR) – Led CE Marking projects for Class I, IIa, IIb and III medical devices, including SaMD. – Authored and remediated full Technical Documentation (MDR Annex II & III): GSPR, RMF, CER, V&V, PMS/PSUR, IFU, UDI. – Conducted MDR transition projects: gap analysis, remediation plans, change control and regulatory impact assessment. – Supported clinical evidence and usability engineering reviews in line with MDR and MDCG guidance. – Managed submissions and technical exchanges with Notified Bodies (BSI, TÜV, AFNOR). – Performed ANSM remediation activities and regulatory follow-up. – Software Medical Devices - IEC 62304 & IEC 82304-1 Expertise – Led and supported end-to-end compliance of Software as a Medical Device (SaMD) in accordance with IEC 62304 and IEC 82304-1, from software lifecycle definition to audit-ready technical documentation. – Defined and implemented software development lifecycle (SDLC) processes aligned with MDR requirements, including software safety classification, architecture definition, configuration management, and change control. – Structured and reviewed software risk management activities, ensuring alignment between IEC 62304, ISO 14971 and clinical risk considerations. – Coordinated cross-functional teams (Regulatory, Clinical, Quality, R&D, IT) to ensure traceability between software requirements, risks, verification & validation activities. – Reviewed and approved software verification and validation strategies, test plans, reports, and anomaly management to support CE Marking and Notified Body expectations. – Supported Notified Body technical reviews and audits (AFNOR) for SaMD, addressing findings related to software lifecycle, documentation consistency and risk control effectiveness. – Provided training and coaching to development and product teams to ensure sustainable compliance and autonomy on IEC 62304/82304-1 requirements. – Integrated cybersecurity requirements into software lifecycle and technical documentation, in line with MDR, MDCG guidance and IEC 81001-5-1, including security controls verification and vulnerability management. – FDA Regulatory Support (510(k), De Novo, BLA) – Conducted regulatory pathway assessment and predicate device analysis. – Prepared and reviewed core 510(k) submission sections. – Consolidated verification & validation evidence for FDA submissions. – Ensured QMS alignment with 21 CFR 820. – Prepared and submitted eSTAR dossiers, ensuring completeness, internal consistency and technical robustness. – Supported FDA interactions, including Q-submissions, deficiency responses and follow-up communications, in coordination with cross-functional teams. – Post-Market Surveillance (PMS), PSUR & PMCF - MDR – Designed, implemented and maintained Post-Market Surveillance (PMS) systems in compliance with MDR Articles 83-86, adapted to device class and risk profile (including SaMD). – Authored, reviewed and updated PSURs for Class IIa, IIb and III devices, ensuring consistency with clinical evaluation, risk management and vigilance data. – Defined PMS plans and procedures, including data collection sources (complaints, vigilance, trend reporting, clinical follow-up, literature). – Performed trend analysis and signal detection, translating PMS outputs into risk management updates, CAPA and design or process changes. – Ensured alignment between PMS, PSUR, RMF, CER and PMCF, supporting Notified Body reviews and audit readiness. – Supported Notified Body and authority interactions related to PMS/PSUR findings, including responses to questions and remediation actions. – FDA & ANSM Inspection Remediation – Active contribution to remediation plans following inspections conducted by the Food and Drug Administration (FDA) and the Agence nationale de sécurité du médicament et des produits de santé (ANSM). – Review and detailed analysis of inspection observations (FDA Form 483, inspection reports, deficiency letters). – Performance of root cause analyses (5 Whys, Ishikawa) and definition of robust CAPAs (Corrective and Preventive Actions). – Contribution to the preparation of formal responses to health authorities within regulatory timelines. – Cross-functional coordination with Quality, Regulatory Affairs, R&D, and Manufacturing teams to ensure global compliance. – Monitoring of CAPA effectiveness and verification of issue closure through internal audits or follow-up inspections. – Market Access Regulatory Strategy – Definition and implementation of regulatory strategies for market access and product lifecycle management in compliance with EU and US regulatory frameworks. – Assessment of regulatory pathways and applicable submission routes (e.g. CE marking under MDR, 510(k) submissions) to support initial market entry and post-market changes. – Evaluation of the regulatory impact of product and process changes on existing approvals, registrations, and technical documentation.

– Led the implementation, maintenance and continuous improvement of an ISO 15189-compliant Quality Management System within a university hospital laboratory environment. – Coordinated quality activities across multiple laboratory specialties, acting as a key interface between laboratory staff, management and accreditation bodies. – Method Verification & Validation – Built, reviewed and maintained method verification and validation files in compliance with ISO 15189 requirements. – Defined and implemented verification and validation protocols (precision, accuracy, repeatability, reproducibility, linearity, measurement uncertainty). – Ensured traceability and robustness of analytical results, from protocol definition to validation reports and routine use. – Supported the introduction of new analytical methods and technologies, ensuring regulatory compliance prior to routine implementation. – Metrology & Equipment Management – Managed the laboratory metrology system, including verification, calibration and monitoring of measuring and testing equipment. – Defined metrological verification plans and ensured compliance with calibration schedules and acceptance criteria – Oversaw equipment qualification and performance monitoring, ensuring measurement reliability and traceability to reference standards. – Managed deviations related to metrology and implemented corrective actions when necessary. – Audits, Risk & Quality Processes – Ensured compliance with accreditation requirements, including document control, internal audits, management reviews and CAPA management. – Managed risk-based approaches related to laboratory processes, equipment, reagents and pre-analytical, analytical and post-analytical phases. – Oversaw non-conformity management, root cause analysis and implementation of effective corrective and preventive actions. – Delivered quality training and awareness sessions to laboratory personnel, promoting a strong quality culture and continuous improvement mindset.

– Led and supported the implementation, maintenance and continuous improvement of a Quality Management System compliant with ISO 15189 within a clinical laboratory environment. – Ensured compliance with accreditation requirements, including document control, internal audits, management reviews and corrective/preventive actions (CAPA). – Coordinated quality activities across laboratory sections, acting as a key interface between technical staff, management and accreditation bodies. – Supported method validation and verification processes, ensuring traceability, result reliability and compliance with regulatory and accreditation expectations. – Managed risk-based approaches related to laboratory processes, equipment, reagents and pre-analytical/analytical/post-analytical phases. – Oversaw non-conformity management, root cause analysis and implementation of effective corrective actions. – Delivered quality training and awareness sessions to laboratory personnel to promote a strong quality culture and continuous improvement mindset.

– Management of NF 50-056 certification – Management of ISO 9001 certification – External evaluation & audit management – Full QMS deployment