Marta Walker has held various positions in the Quality Assurance and Regulatory Affairs field since 2000. Marta started their career in software engineering and logistic engineering at Intershop and Siemens. In 2006, they joined Nucletron, an Elekta Company, as Quality Assurance & Regulatory Manager Scandinavia- Radiotherapy Devices, where they were responsible for establishing and maintaining the quality management system. In 2013, they moved to Roche Diagnostics as Quality Assurance Manager, working on IVD projects. In 2015, they joined Philips as Head of Regulatory Affairs & Quality Assurance - Philips, working on Innovation Site Eindhoven (OTC devices) and Image Guided Therapy. In 2020, they joined STENTiT as Head of QA & RA, and in 2021, they joined OneProjects as Dir QA&RA.
Marta Walker's education history includes a Master in IT Management from KTH Royal Institute of Technology (2002-2005) and an Engineering degree from Pontifícia Universidade Católica do Rio de Janeiro (1986-1992). Marta also has a number of certifications, such as Medical Device Reporting from Anson Group (2011), ISO 140001- Environmental Quality Management Systems from Det Norske Veritas (2011), Clinical Evaluation of Medical Devices from KEMA (2010), Auditing Quality Management Systems from Emergo Group (2010), Clinical Investigator: Responsibilities in Medical Device Trials from US Food and Drug Administration (2009), Good Clinical Practice from US Food and Drug Administration (2009), Introduction to Bioresearch Monitoring Program from US Food and Drug Administration (2009), The Sponsor: Responsibilities in Medical Device Clinical Trials from US Food and Drug Administration (2009), 510(k) and 513(k) from US Food and Drug Administration (2009), How to get your Electronic Product in the US Market from US Food and Drug Administration (2009), Overview of Regulatory Requirements: Medical Device from US Food and Drug Administration (2009), Quality System Regulations 21CFR 820 from US Food and Drug Administration (2009), Introduction to Radiotherapy (2008), Establishing Compliance with Medical Device Directive from Cameron Quality Consultant (2006), and ISO 13485 Quality Management Systems from Cameron Quality Consultant (2006).
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