Summary
Overview
Work history
Education
Skills
Languages
Certification
Timeline
Generic
MARIA CRISTINA LA MANNA

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
2023.10 - 2025.12
  • 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
2022.10 - 2023.04
  • 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
2024.02 - 2025.02

Master's Degree - Biomedical Engineering

POLITECNICO
Milan
2020.05 - 2023.05

Bachelor's Degree - Biomedical Engineering

LA SAPIENZA
Rome
2016.09 - 2019.12

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
2024.02 - 2025.02

Healthcare Domain Consultant

ALMAVIVA S.P.A
2023.10 - 2025.12

Curricular Internship

HUMANITAS CLINICAL INSTITUTE
2022.10 - 2023.04

Master's Degree - Biomedical Engineering

POLITECNICO
2020.05 - 2023.05

Bachelor's Degree - Biomedical Engineering

LA SAPIENZA
2016.09 - 2019.12
MARIA CRISTINA LA MANNA