MARIA CRISTINA LA MANNA
Rome,Rome
Summary
Biomedical Engineer specializing in healthcare digital solutions and medical device quality and regulatory affairs, including ISO 13485 and MDR compliance. Proven expertise in business analysis and R&D for innovative software technologies, with a strong focus on functional documentation and stakeholder collaboration.
Overview
3
3
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work history
Healthcare Domain Consultant
ALMAVIVA S.P.A
Rome
10.2023 - 12.2025
- Achieved ISO 13485 certification for Quality Management System in medical device distribution.
- Designed innovative solutions tailored for Healthcare sector needs.
- Prepared tender responses for Healthcare Framework Agreements.
- Re-engineered information services for Public Administrations, including AIFA and Ministry of Health.
- Ensured regulatory compliance by drafting procedure manuals and conducting audits.
- Collaborated with industry professionals to enhance project delivery effectiveness.
Curricular Internship
HUMANITAS CLINICAL INSTITUTE
Milan
10.2022 - 04.2023
- Conducted experimental tests for characterising pancreatic tissue using BioIndenter UNHT.
- Collected experimental data and performed statistical analysis.
- Utilised MATLAB for computational modelling.
Education
Second-Level Interdisciplinary Master’s Degree - Medical Technologies Regulatory Affairs
LA SAPIENZA
Rome 02.2024 - 02.2025
Master's Degree - Biomedical Engineering
POLITECNICO
Milan 05.2020 - 05.2023
Bachelor's Degree - Biomedical Engineering
LA SAPIENZA
Rome 09.2016 - 12.2019
Skills
- Business analysis expertise
- Regulatory compliance and quality assurance
- Functional requirements analysis
- Innovative IT health solutions R&D
- Stakeholder communication and collaboration
- Technical documentation drafting
- Figma design prototyping
- Agile, Scrum, and ITIL knowledge
- MATLAB basic programming
Languages
English
Proficient (C2)
Italian
Native
Spanish
Intermediate
Certification
- Pearson English International Certificate CEFR C2
- ITIL Foundation Certificate in IT Service Management
- Internal Auditor for Quality Management Systems with specific application to Medical Devices UNI EN ISO 13485:2021
- IQBBA Certified Foundation Level Business Analyst
- Agile Scrum for Beginners & Professional Scrum Master
- ECBA Entry Certificate in Business Analysis
- PRINCE 2 Agile Foundation
Timeline
Second-Level Interdisciplinary Master’s Degree - Medical Technologies Regulatory Affairs
LA SAPIENZA
02.2024 - 02.2025
Healthcare Domain Consultant
ALMAVIVA S.P.A
10.2023 - 12.2025
Curricular Internship
HUMANITAS CLINICAL INSTITUTE
10.2022 - 04.2023
Master's Degree - Biomedical Engineering
POLITECNICO
05.2020 - 05.2023
Bachelor's Degree - Biomedical Engineering
LA SAPIENZA
09.2016 - 12.2019