Acerca de Manal
- Clinical study coordination and follow-up support
- Patient communication and participant support
- Study logistics (scheduling, tracking, coordination of activities)
- Clinical documentation and data entry support
- Literature review and research assistance
- Cross-functional communication between clinical, research, and operational teams
- Administrative support for healthcare and clinical projects
- Clinical nursing experience (ICU, OR, inpatient care)
- Hands-on use of medical devices in real hospital settings
- Exposure to healthcare systems and public health concepts
- Academic foundation in epidemiology and health economics
Árabe
Bilingüe o nativo
Inglés
Competencia profesional completa
Francés
Competencia profesional completa
Experiencia
- PROMAMECRegulatory Affairs Trainee – EU MDR Implementation and export projectmarzo de 2023 - agosto de 2023 (5 meses)
- Supported regulatory documentation alignment for Class IIa and IIb medical device procedure kits in preparation for EU MDR compliance and CE-marking processes targeting European market access.
- Worked on technical documentation updates for single-use surgical kits composed of imported and locally manufactured components, ensuring documentation consistency across product descriptions, labeling, applicable regulations, standards, and supplier-related information.
- Reviewed and organized regulatory documentation including risk, performance, and technical data to improve file completeness and facilitate alignment with EU MDR requirements.
- Collaborated with regulatory, technical, and cross-functional teams to maintain updated documentation and support progress of CE-marking preparation activities.
- Contributed to the development and documentation review of 7 surgical procedure kits, integrating both regulatory requirements and end-user clinical considerations based on healthcare workflow knowledge.
- CHU de BesançonClinical Investigation Intern – Medical Devices – Pre-CE MarkSECTOR MÉDICOnoviembre de 2022 - enero de 2023 (2 meses)Besançon, Francia
- Contributed to development of a Clinical Investigation Plan (CIP) for a Class II medical device intended for home-use adaptation.
- Supported study design development including endpoints, patient eligibility criteria, follow-up schedules, and outcome measures.
- Contributed to clinical documentation aligned with EU MDR and ISO 14155 requirements for CE-marking preparation.
- Reviewed prior clinical studies, PMCF data, and safety/performance evidence to support clinical strategy.
- Ministère de la Santé marocaineAnesthesia and Intensive Care NurseSECTOR MÉDICOjunio de 2020 - agosto de 2021 (1 año y 2 meses)Morocco
- Worked in high-pressure hospital environments during the COVID-19 pandemic, managing care delivery in isolation units with complex and rapidly evolving protocols.
- Faced with critical patient flow challenges and infection control constraints, I coordinated daily operations alongside multidisciplinary teams including physicians, military medical staff, and civilian nurses. I acted as a team support lead within a group of healthcare professionals, ensuring continuity of care and effective communication across stakeholders.
- Provided direct patient care in ICU and inpatient settings, ensuring adherence to clinical protocols, patient safety, and quality standards under high-risk conditions.
- Supported clinical decision-making and operational coordination for patient transfers to higher-level care units (including intensive care and emergency services), in collaboration with attending physicians.
- Contributed to clinical education by informing patients and families about disease conditions, isolation protocols, and treatment pathways, improving understanding and adherence to care procedures.
- Trained nursing students on the use of medical devices and supported proper application in clinical settings, contributing to risk reduction and procedural compliance.
- Participated in laboratory-related processes including biological sample collection, labeling, documentation, and handling, ensuring accuracy and traceability of clinical data.
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Formación
- Master of Science, Technology, Health – International Master in Biomedical EngineeringInstitut Supérieur d’Ingénieurs de Franche-Comté (ISIFC)2023Master 2
- International Master’s Degree in Biomedical EngineeringAbulcasis International University of Health Sciences - UIASS2022Master 1
Certificados
- Essentials of European Medical Device Regulations (EU MDR)-2017/745Alison2023
- ISO 13485:2016 - Quality Management Systems for Medical DevicesAlison2022
Conjunto de habilidades profesionales
Categorías
- Otros