Joan Hereter Gregori Email & Phone Number

Barcelona, Ct, Es

Barcelona, Catalonia, Spain

Project Management:- Implement and maintain project management methodologies, frameworks, and best practices.- Lead projects involving complex neuroscience devices, from development to clinical trials and regulatory submissions (FDA and MDR).- Provide project governance and ensure adherence to organizational standards and policies.- Monitor and report project performance, including tracking key metrics and KPIs.- Support the development and implementation of project management tools and software.- Provide training and mentorship to project managers and team members on project management principles and practices.- Contribute to writing proposals for the European International Council accelerator program.- Act as a key contributor in the development and implementation of product design and development processes, risk management protocols, and change control management procedures within the quality management system (ISO13485).Product Management:- Develop, define, and oversee the products’ roadmap and managing it as required for the purpose of meeting deliverables for the business.- Lead product lifecycle and development of the company's most strategic products- Incorporate the existing development backlog and making priorities as determined by the business, consumer, and market needs. Product change management coordinator, managing changes to finished products.- Translate business objectives into the strategy of the assigned product/product group appropriately involving the rest of the organization.- Engage extensively with consumers in order to gain first hand insight on the consumers’ and market feedback on the business’s product.- Conduct relevant product research, establish competitive intelligence, and various market analyses. Conduct user and market research that further aids the business in understanding current and future product needs.

Barcelona, Catalonia, Spain

- Oversee and manage multiple projects simultaneously, ensuring their successful execution and completion within established timelines, budgets, and quality standards (ISO13485, ISO14971, ISO10993, IEC60601, IEC62304, IEC62366, etc.)- Provide leadership and guidance to project teams, assigning responsibilities and monitoring progress.- Collaborate with cross-functional teams to align project goals, resources, and priorities.- Develop and maintain project plans, defining scope, objectives, and milestones.- Identify and mitigate risks and issues, implementing contingency plans as needed.- Foster effective communication and collaboration among project team members and stakeholders.- Bring a broadened business perspective to each project through an understanding of the inner-workings of Marketing, Engineering, Clinical Operations, Regulatory Affairs, Quality, Manufacturing and Logistics

Barcelona Area, Spain

Clinical trials and technical specialist in the Cardiac Rhythm Management branch of Microport (mainly Pacemakers, ICDs and CRTs).- Assist clinical sites / investigators in successful execution of Clinical Trials- Provide technical support to doctors and hospital personnel during cardiac devices implant procedures and follow-ups- Ensure timely submission of protocol / consent document for EC/IRB approval- Perform site training and clinical studies start-up (SIVs)- Collaborate with CRA and monitoring to ensure site data compliance and integrity- Develop strong relationship with doctors and investigators- Transfer knowledge and ideas from investigators to new product development

Barcelona, Catalonia, Spain

- Founded and successfully established an e-commerce company specializing in yoga and meditation products, overseeing all aspects of the business from inception to growth.- Conducted market analysis to identify target audiences, assess competitors, and determine optimal product offerings, resulting in strategic business decisions and targeted marketing campaigns.- - Established and nurtured relationships with international providers, negotiating favorable terms and sourcing high-quality products, ensuring a diverse and competitive product portfolio.- Implemented efficient supply chain management processes, optimizing inventory management, order fulfillment, and logistics to ensure timely delivery and customer satisfaction.

Victoria (Canada), Toronto (Canada)

- Guide device technical design, problem solving, experimentation, and testing- Lead the Design History File (DHF) documentation effort following the company's Quality Management System (QMS) and ISO13485 requirements - Lead technical content of FDA 510(k) regulatory submissions, and support the development of regulatory strategies- Develop manufacturing strategy, and evaluate and improve assembly processes- Support and review of human factor activities (e.g. usability testing with end users)- Plan for integration and systems level testing- Communicate with clients on a regular basis to provide technical updates and work through timeline and technical risk challenges- Resource projects and assign and manage tasks within budget, schedule and quality expectation- Scope and estimate remaining time, project change requests and new statements of work- Develop new business proposals

Victoria (Canada), Toronto (Canada)

- Prepare and maintain project risk registry and project plans, and set/adhere to milestones, deliverables and budgets- Ensure team meetings, project reviews and action lists are kept current and communicated to all stakeholders in a timely fashion- Manage project resource planning- Manage client expectations and report on project progress regularly- Interface with Business Development to transfer new activities into Engineering- Support documentation requirements in accordance with ISO13485- Support design transfer to production and provide on-going Engineering support - Develop test plans, execute verification testing and write detailed test reports for a variety of products - Design of solid models, assemblies and detailed component drawings using SolidWorks

Victoria, British Columbia, Canada

- Work with the product development team to create product specifications to meet customer requirements and mitigate risks.- Design for manufacturing (injection molding, over-molding, silicone molding, machining, rapid prototyping, laser cutting, sheet metal, casting), assembly (mechanical, gluing, in-line QC testing, snap fitting) and other secondary operations (pad printing, powder coating, painting, labeling, packaging). - Support documentation requirements in accordance with ISO13485 including but not limited to product specifications, risk analysis and verification test protocols. - Prepare suitable documentation for 60601-1 Electrical Safety Testing, 3rd Edition.- Develop Test Plans and Methods for a variety of Products. - Execute Verification Testing and Write detailed Test Reports. - Understanding of good documentation practices. - Create solid models, assemblies and detailed component drawings using SolidWorks. - Familiarity with tolerances for different manufacturing processes - Manage client expectations and report on project progress regularly. - Provide contributions to projects that lead to customer success.- Perform internal audits.

Montreal, Canada

- Execute testing and reporting for regulatory submission for the iAssist Knee System (FDA 510(k) number: K141601)- Develop and design the company products, and define and execute test protocols for the product design verification and validation.- Interact with the software, instrument, electronic and test teams, and external collaborators.- Ensure that quality standards ISO13485 are followed during development to guarantee safety and efficacy.

Région De Montréal, Canada

- Write the class notes for the course GTS503 – Health care technologies, standards and certification at École de technologie supérieure (ÉTS).- Develop a website dedicated to health care technologies.

Master Of Engineering (M.Eng.), Biomedical/Medical Engineering, Best Biomedical Thesis Of The Year

Activities and Societies: University Soccer Team Master's Thesis at Laboratoire de recherche en imagerie et orthopédie (LIO)

Internal Auditor Training, Iso 13485:2003 (Medical Devices – Quality Management Systems – Requirements For Regulatory Purposes)

Engineer'S Degree, Industrial Engineering