Mara Rolando

- Reporting to the CEO and part of the Leadership Team of the organization, responsible for the implementation of the organizational strategy and the operational portfolio, maintaining control of project costs, risks, schedules and deliverables, acting as change manager. Interfacing with all business units in optimizing their BU strategies, portfolio management, and processes, leading cross-functional teams across the organization and being the single point of contact for the strategy alignment, return of investment and strategic business plans. - Directly liaising with the Council Board and other key governance groups to report on progresses, support decision-making, improve processes, and target operational excellence. Leading the ISO strategy revision in 2023. - Leading the digital transformation of ISO through the identification and creation of new products and services, including the assessment of the implications to the production lifecycle, the business model, and the definition and delivery of a sustainable operational structure ensuring continuous delivery and evolution to meet users’ needs. - Directing and continuously improving project management processes by harmonizing best practices and implementing digital solutions to improve the consistency and efficiency across all departments. - Managing a team of project managers, responsible for strategic and operational projects.

PMO manager from May 2018 to December 2019, then promoted to Head of PMO. - Ideated, defined and built a Project Management Office including the streamlining of the portfolio reporting process, the review of the strategy implementation and project control strategy, and the enhancement of the project management maturity by supporting PMs in their day-to-day activity. Created and disseminated unified tools and processes, including portfolio management tool and change management processes. Established new workflow for resource allocation and budgeting. - Maintain control of project costs, scope, deliverables and schedules, addressing escalations and risk mitigations. Screening incoming business ideas/request and develop execution strategy. Promoting the culture of innovation within the company. - Act as Procurement Management Officer to drive evolution of processes, roles and responsibilities, ensuring audit-proof documentation, as well as assisting and guiding on the day-to-day execution of tender activities before transitioning the role to the operational team. - Management of large-scale, strategic and sensitive projects in the area of Production (processes review and reorganizational structure of the business unit), Human resources (design of new processes for HR performance review and related HRIS implementation), Communication (organizational engagement and change management), PMO (selection and implementation of PPM), etc.

- Directly managed global programs for the Clinical Quality and Regulatory departments in medical devices (e.g. restructuring of the production chain for the cardiopulmonary product line, including related quality and regulatory processes). - Manager of all clinical applications and responsible for the clinical portfolio reporting, including support for new products launch. - Defined and promoted PM processes and good practices in multiple departments and different divisions (CRM, Heart valves, Cardiopulmonary and Neurostimulation). - Trained and mentored PMs on processes and tools. - Implemented new data gathering and data review processes and reporting tools on safety management and regulatory management. - People manager for clinical project assistants’ team, responsible for resource leveling of CRAs across all countries, and managing output of 30-person team across multiple countries on specific projects.

- Designed, planned and executed multiple clinical trials on medical devices (ICD, PM, Holters, leads) worldwide (Europe, North America, Australia and Asia). - Managed internal and external customers and key stakeholders. - Collaborated with the marketing, biometry, research and scientific communication teams on data analysis, publication and product launches. - Constant support for IRB/EC submission, initiation visit, as well as directly managed adverse events reporting in accordance with the international regulation and internal SOP.

- Redacted (protocol and CRF) and executed multiple clinical registries worldwide. - Managed CRA and vendor work, board meetings and team training. - Analyzed clinical data on multi-center clinical studies. - Supported medical writing on scientific findings.

- Design, management and execution of different protocols of electrical stimulation on human subjects. - Prototyping of rehabilitation solution for patients suffering from partial jaw removal. - Development of Java application for biomedical image processing.

High Performance Board Program