Marisa Leite
Project Manager (PMO) | Regulatory & Software
Salary / Daily rate
Lisbon, Portugal
Freelance, open to permanent contract
Can come onsite
Skills
Languages
About me
Intro
PMP-certified Project Manager with 7+ years managing complex international projects across healthcare and medical devices. Led FDA submissions, global product launches across 4 continents, and cross-functional teams while ensuring regulatory compliance. Specialized in software implementation, workflow optimization, and delivering projects on time and within budget.
Work experience
Project Manager (PMO)
miDiagnostics
Jan 2022 - Present
4 years 10 months
Lovaina, Fandre, Bélgica
Successfully managed complex projects and led cross-functional teams, achieving milestones on time and within budget while ensuring compliance at every stage of the project lifecycle •Software Implementation & Workflow Optimization: Worked closely with product and development teams using Jira, Figma, Spira, and Veeva to define and streamline workflows •User-Centered Testing & Support: Led planning and monitoring of software testing (automated, UAT, internal validation, and usability testing) to ensure strong user experience and alignment with real-world needs •Customer Services & Tool Rollouts: Managed customer-facing workflows using ERP and Zoho; implemented tools and processes to support onboarding and ongoing use •Cross-Functional & International Collaboration: Acted as a key link between technical and non-technical teams, including quality, software, operations, and external partners •Project Office Setup: Created and rolled out project templates, charters, and reporting routines (SteerCo, budgets, resource plans), contributing to long-term structure in a growing team •Regulatory Experience: Coordinated FDA assay submission projects, including software and cybersecurity documentation
Baxter International Inc.
Nov 2018 - Oct 2021
3 years
Brussels, Belgium
Project Manager (PMO)
Nov 2020 - Oct 2021
1 year
Brussels, Belgium
•Portfolio Manager of Marketed Devices: cross-functional assessment and change requests implementation (TrackWise) •PM Lead of Change Control Board for all Advanced Surgery Portfolio
Project Manager (PMO)
Nov 2018 - Dec 2020
2 years 2 months
Brussels, Belgium
•Launch and Geographic Expansion in Asia, Africa, North & South America and Europe for all Renal Care Portfolio •Development of processes and workflows to streamline launch procedures •Analysis and creation of business cases for each country to support strategic decision-making by the Marketing Director •Enhancement of relationships and coordination of efforts with local and global Regulatory Affairs (RA) teams to ensure alignment and successful collaboration
Project Manager (PM)
HOP CONSULTING
Feb 2017 - Oct 2018
1 year 9 months
Porto, Portugal
− Public Procurement Procedures - Incentives Programs (European Union Funds): Portugal 2020 − Project Management (Internationalization, Qualification, Innovation, Entrepreneurship, etc) − Market Reports / Strategic Plans / Marketing Plans > GDPR - Training
Education
Escola de Engenharia da Universidade do Minho
Master's degree
2014 - 2016
2 years 1 month
Escola de Economia e Gestão - Universidade do Minho
Bachelor's degree
2011 - 2014
3 years 1 month
Escola Secundária de Ferreira de Castro
Economics
2008 - 2011
3 years 1 month