Firas Alani

Clinical Evaluation, EU MDR & Notified BodyActivities Clinical assessment of Clinical Evaluation documentation in support of CE marking for medical devices. Evaluation of Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices. Review of Periodic Safety Update Reports (PSUR) in compliance with EU MDR requirements. Contributed to internal Notified Body audit readiness through consistent application of EU MDR requirements, standardized documentation practices, and cross-functional alignment. Contributed to continuous improvement of clinical assessment processes through structured review methodologies, risk-based prioritization, and assessor alignment activities. Supported the maintenance of accreditation through participation in internal assessments, assessor calibration activities, and documentation standardization.

Medical DeviceVigilance – Team Leadership Management and coordination of a global medical device vigilance team (vigilance managers, physicians and officers). Oversight of global medical device vigilance operations, ensuring regulatory and quality compliance. Supervision of post-market safety and vigilance documentation (PMS plans/reports, PSURs, trend reports, CERs). Contribution to product risk–benefit assessments throughout the product lifecycle. Interface with competent authorities and notified bodies. Preparation and support of audits and inspections; implementation of CAPA. Led preparation activities for internal audits, MDSAP audits, and competent authority inspections, ensuring readiness ofvigilance documentation, PSURs, PMS files, trend analyses, and CAPA evidence. Directed pre‑audit gap assessments, coordinated cross‑functional corrective actions, and ensured timely closure of audit findings. Served as primary interface with auditors during MDSAP and regulatory inspections, providing medical justifications, process explanations, and evidence supporting regulatory conformity. Implemented audit‑driven continuous improvement actions to strengthen vigilance workflows, complaint handling quality, and risk‑benefit assessment processes. Developed standardized vigilance workflows, templates, and metrics to improve operational efficiency and reduce variation.

EMEAClinical Implementation,Training & Emerging CardiacTechnologies Provided clinical and technical field support for emerging Heart Failure and Cardiac Rhythm Management (CRM) technologies across the EMEA region. Management of heart failure patients using pulmonary artery pressure monitoring systems (CardioMEMS) and leadless pacemakers (Nanostim). Ensure site technical readiness and site initiation visits (SIV), including technical data collection. Training programs and mentoring for investigators and site staff on device implantation and procedures. On-site follow-up support and troubleshooting, and relayed technical and clinical feedback to R&D and development teams.