Angelica Marcia
Regulatory Expert - Digital Software Products @Fresenius Medical Care
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WORK HISTORY
Regulatory Expert - Digital Software Products @Fresenius Medical Care
Act as regulatory project lead for change-related activities • Coordinate global product change management, regulatory requirements, product availability across international markets (incl. registrations, submissions, notifications to Notified Bodies and Regulatory Authorities), oversee local evaluations of regulatory impacts • Manage Global Product Technical Documentation (incl. expert opinion, risk evaluations) • Coordinate regulatory strategies and roadmaps in accordance with company’s commercial strategy • Provide regulatory expertise to support identification of applicable compliance standards, design and development projects, global agency audits, clinical studies and regulatory KPIsProduct scope: Digital Software (global) e.g clinical data & monitoring management, digital solutions to enhance dialysis treatment
EDUCATION
Studienkolleg München
Medicine Course
Technical University of Munich
Bachelor of Science - BS
Ludwig-Maximilians-Universität München
Medicine
Tarakanita 1 Senior High School
High School Diploma • Valedictorian
ABOUT ANGELICA MARCIA
Hard-working professional with 4+ years of experience in QA/RA for medical devices, complemented by 7+ years of experience with different healthcare stakeholders (payor, 10+ inpatient/outpatient hospital departments, sleep medicine lab). Successfully led cross-functional teams (9+members) to achieve QMS/ISM certifications (ISO 13485, ISO 27001) while leading the regulatory pathway for innovative AI-based in-vitro diagnostic (IVD) software products. Regulations/Standards: • UK and EU (IVDD/IVDR, MDD/MDR), US (510k, De Novo, PMA, FDA Breakthrough Designation, LDT) • ISO 13485 (QMS incl. CAPA, Internal and External Audits, Quality Management Review, Supplier Management, and KPI’s/Data Analysis), ISO 14971 (Clinical Risk Management), IEC 62304 (Software Lifecycle), IEC 62366 (Usability), PMS/PMPF • ISO 27001 (Information Security), GDPR, DPIA, Cyber Essentials • SaMD (Software as Medical Device), IVD (In-Vitro Diagnostic), AI-based MD
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