María Fernanda Bianco Email & Phone Number

Barcelona, Catalonia, Spain

Miami, Florida, United States

Focalyx is a MedTech company that manufactures Software as a Medical Device (SaMD) solutions to support the diagnosis and treatment of prostate cancer.• Defined the business strategy for the company and set OKRs. Achieved a 30% YoY total device use growth (2022, 2023)• Automated internal and customer service processes via low code/no code tools: specifications, tests and traceability (JIRA, X-RAY, SoftComply Risk Manager); supply chain, marketing and customer care (Monday.com); travel and expense management (Navan)• Implemented a QMS compliant with ISO 13485, ISO 14971, FDA and EU (MDD, MDR) requirements: acquired a No Action Indicated (NAI) during the first FDA inspection after clearance (August 2023) and obtained ISO 13485 certification by a Notified Body (January 2024)• Led the implementation and go-live of a new upgrade of the Focalyx Fusion SaMD (IEC 62304 compliant) to attain third party hardware independence. Allowed the company to obtain a 23% cost reduction related to host PC specifications• Led the Planning Tool project: direct management of a team of 4 researchers from University College London for the design & development of a new SaMD (IEC 62304 compliant) dedicated to prostate MRI viewing, annotation and preprocedure planning. Demonstrated a first complete prototype at the American Urology Association’s Annual Meeting (May 2024)

Barcelona Area, Spain

Sopra Steria is a multinational company focused in consulting, digital services and software development.• Led the planning and execution of a new customs clearance application (PM of a team of 15 based in France & Spain) & a new social security application for the french freelance population (PM of a team of 5 based in France & Spain)• Monitored and controlled scope, schedule, budget, quality and risks (up to 3M€/year with mandatory EU Go-Live dates)• Built strong stakeholder engagement: from the program direction to the collaboration of onshore & offshore teams• Promoted a workload and budget follow-up method using JIRA and PowerBI, which was showcased as a best practice at the Group level• Improved the onboarding experience during the first wave of the pandemic (impact on +40 newcomers to the French Customs Program) by summarizing +6 years' complex content into attractive, easy to read material: a checklist & welcome guide, baby steps flashcards, clear transfer & onboarding plans & a video blog• Initiated and co-founded WIN, a program designed to advocate for equal opportunities for women in STEM. The program was adopted and launched at a national level (Spain)

Barcelona Area, Spain

Grupo Planeta is a Spanish multinational company focused on media and entertainment services.• Guaranteed the competition of a previously 2-year frozen backlog by proposing and implementing a one-year plan to reinforce the Application Maintenance (AM) IT team• Regained the business users trust by implementing a new ticket definition & prioritization process using JIRA • Acted as a Product Owner for projects developed with external providers, from definition to implementation

Barcelona Area, Spain

Tech Data is a global IT distribution company.• Decreased the +200K debt of a German customer by handling disputes with the use of more transparent information of SLAs follow-up through a more visual, simpler reporting using SAP FI & BW

Madrid Area, Spain

NH Hotel Group is a Spanish hotel chain headquartered in Madrid, Spain that operates over 350 hotels in 35 countries.• Regained business ownership in the B2B Sales by prioritizing the entire IT backlog (+200 requests) through the design of a new process: setting a roadmap, identifying key users by Business Unit & developing communication channels

Palo Alto, California

HBI Solutions is a healthcare data management company focused on risk reduction, care quality improvement and cost reduction.• Analyzed the Medicare Access and CHIP Reauthorization Act (MACRA) legislation and provided support for the proposal for the development of new business opportunities regarding the implementation of new metrics and links into the existing HBI solution• Assisted the management of the design, development, testing and product support of a healthcare database software in a start-up work environment

Madrid Area, Spain

• Researched and synthesized European Union countries’ legal initiatives to support human rights protection in their Corporate Social Responsibility national frameworks• Developed a proposal to include social responsibility concerning human rights violation by private enterprises in the Spanish legislationA Clínica Jurídica ICADE project, under the supervision of Garrigues and Amnesty International

Oral and Written Expression Workshop (Subject)• Participated in the development of educational and academic research strategies

Universidad Central De Venezuela

Editor of the "Agujero Negro" magazine, main communicative organ of the Arts' School, Humanities and Education Faculty, Universidad Central de Venezuela. Awarded with the Mérito Estudiantil (2012).• Developed and coordinated the magazine’s text selection process for each issue. • Participated in the development of three magazine issues’ themes.• Corrected and edited texts.

Advanced Leadership Program In Healthcare

Activities and Societies: Awarded with the IE Scholarship for Women.Joint program between IE Business School and King's College London..

Design Thinking For Business Transformation, Design Strategy

The concepts of problem solving, creativity, co-creation and customer value are becoming crucial in any business strategy, helping.

Master'S Degree, Economics, Politics & Law With A Main Focus On Business & Economics, 8.5/10

Activities and Societies: Clínica Jurídica ICADEThe Official Master's Degree in Economics, Politics and Law has a multidisciplinary.

International Seminar Within The Master Of Economics, Politics And Law, International Economics

Liberal Arts, Liberal Arts And Sciences/Liberal Studies, Summa Cum Laude

Activities and Societies: Agujero Negro Magazine, Proyecto Ciénaga & Teacher Assistant developmentThe Liberal Arts degree is a 5-year.

International Summer School, English Language And Literature, General

Cours De Langue Et Civilisation Française, French Language And Literature