Laura Magaña, founder and Regulatory Affairs Compliance Director, has gained over 20 years of experience and a broad expertise leading compliance in small, medium and large size companies.
Laura’s area of expertise ranges from medical devices, ‘in vitro’ diagnostic medical devices (IVDs); health & food safety to animal health, cosmetics and digital health industries. In addition, she has led and successfully delivered both face-to-face and e-learning courses for professionals.
Laura has a Pharma Degree by Alcala de Henares University (UAH), Madrid. Her knowledge and experience in Quality, Regulatory & Clinical Affairs makes her an expert in the process of affixing CE marked; building and implementing quality management systems, auditing; orchestrating vigilance and post-market surveillance activities and coordinating compliance obligations within the supply chain.
Amongst her notable work experience, it is worth highlighting that Laura has served to the Vigilance Unit for medical devices of the Spanish Agency of Medicines and Medical Devices (AEMPS) being responsible for management of incidents and field safety corrective actions as technical reviewer. She is currently an expert member of the British Standards Institution Commitee, ISO/TC 210/WG6 and member of the European Medical Writers Association (EMWA). In addition, she has actively participated in several Working Groups, such as Clinical Evidence, Standardization Quality & Risk Management and General Data Protection Regulation at the European MedTech Trade Association in Brussels.
Given all the aforementioned knowledge and experience, Laura successfully manages European and international projects. Her work across multicultural and multi-functional teams guarantees excellent results in Quality, Clinical and Regulatory Compliance.
Affix Compliance 