Joana Gomes
Marketing & Communication Manager
Joana Gomes is a Marketing and Communications professional with 5+ years of experience, particularly in the field of B2B biotechnology products and services. With a Master's Degree in International Management and strong intercultural communication skills, she has conducted marketing and consumer research in Europe and Asia, which enables her to tailor messages to different target groups effectively. Joana brings Medidee’s services closer to you, by making sure we provide relevant content, materials and trainings to professionals in the industry. She speaks fluent English, Portuguese and Spanish and has intermediate knowledge of French, German and Mandarin Chinese.
Dr Núria Gresa
Project Associate
Dr Núria Gresa a biologist by training and holds a PhD in Biomedicine. She has 10 years of experience in neuroscience and cellular biology research. She has a strong background in clinical and translational research acquired as a postdoc in Hospital Clinic in Barcelona, and in animal models gained in a postdoc at Karolinska Institute in Sweden. During her career she participated at international conferences with oral presentations and published her work in top peer-reviewed journals. Before joining Medidee she worked as an assistant lecturer professor at University Pompeu Fabra in Barcelona, developing strong skills to communicate complex concepts in a simple and approachable way. She has strong competence in clinical investigation, medical writing, data management and statistical analysis. Núria is fluent in English, Spanish and Catalan, with good understanding of French and Italian.
Dr Olivier Gschwend
Project Associate
Olivier Gschwend provides Clinical and Regulatory support related to Medical Devices and In Vitro Diagnostic devices. His expertise, among others, covers clinical evaluation, clinical investigations, clinical strategy, scientific writing, statistics, and management of multidisciplinary projects. Olivier is a trained medical biologist PhD. He has more than 10 years of professional experience in neuroscience research and his work has been published in top-ranked journals. With his deep knowledge of state-of-the-art electrophysiology and imaging neurotechnology, Olivier holds a strong technical expertise in brain implantable devices.
Olivier is fluent in French, English, and German.
Alba Gutiérrez
Senior Associate
Alba Gutiérrez is a biomedical engineer specialized in Medical Imaging and 3D modelling. She holds a Master in Life Science and a CAS CARAQA in Clinical, Regulatory and Quality Affairs for Medical Devices and In-Vitro Diagnostics. Alba supports with QMS deployment, maintenance and auditing. Her competencies include project management, deployment of MDR compliant technical documentation, including risk management, usability and design verification, and validation activities for software and hardware medical devices. She is experienced in preparing FDA 510(k) submissions and supports you in planning your regulatory strategy. Alba is fluent in English and Spanish and has a good understanding of French.
Soizic Guevera
Chief Financial Officer
Soizic Guevera has several years of experience in the Swiss banking industry, during which she has worked in many sectors.
Through working for large companies, she had the opportunity to thrive in complex environments and develop a broad vision of company issues. These experiences enabled her to hone a wide range of skills in banking products, treasury management, implementation of reporting and working tools, cross-disciplinary projects, as well as department organization.
At Medidee, Soizic works in the finance and administrative team, ensuring financial and performance reporting to the Senior Management, performing business analysis as well as supporting group administration activities.
Soizic speaks French, English and Spanish
Pierre Geens
Business Development Regulatory, Clinical, Quality – EU
Pierre Geens has 15+ years of experience working in the healthcare industry in the fields of pharmaceuticals, biotechnologies and medical devices. During his career, he has been managing projects for major industry players, with international exposure and responsibilities in various areas, including aseptic manufacturing, process validation, design assurance, strategic master plans and quality systems implementation at the corporate level. He has also developed cross-functional abilities, working for medical device startups, in quality assurance, regulatory and clinical affairs, market access, business development, reimbursement and research and development. Pierre is ready to help clients to determine the most appropriate development and regulatory pathways to bring novel medical devices to global markets. He can also participate in design review and risk management activities, as well as in the implementation and streamlining of quality management systems. Pierre is fluent in English and French.
Arthur Goddard
Senior Consultant USA
Arthur is a RA/QA professional in the medical device industry since over 36 years. His expertise includes: research, product development, manufacturing, servicing, QC and direct administrative supervision. R&D experience includes obtaining FDA approvals for a large variety of devices and achieving ISO 13485 certification to obtain CE Marking, audited to ISO /GMP regulations, hosted FDA inspections; assisted in design / redesign projects.
Arthur holds a BA degree and is Regulatory Affairs Certified (RAC). He is experienced in photo-therapy equipment, minimally invasive surgical devices, dental cement, liquid bandage, wireless neurological devices, orthopedic surgical devices, in vitro fertilization devices, Class IV laser pain management and therapy equipment, cardio-vascular devices, respiratory devices, and tinnitus masking devices.