Eri Hirumi

Eri Hirumi started her career as a Development Chemist for a very small electrophoresis product line that provided training on a broad spectrum of skills on the complete product life cycle. This training highlighted the key importance of managing documentation. The growing labeling knowledge sparked her interest in other parts of regulatory. This in turn developed a detailed knowledge of world-wide IVD labeling requirements and the interplay with different standards. Eri shifted her career to into Regulatory Affairs. She continues to expand her knowledge on global regulatory requirements. Different requirements such as chemical hazard communication, global registrations, import/export requirements, biological origin permitting and country of origin marking requirement were all interwoven into supporting a complete product life-cycle. Being an auditor for TÜV SÜD provided an excellent platform for building a solid foundation of Quality Management Systems as defined by EN ISO 13485 and the European regulatory processes and documentation requirements. Eri is constantly expanding her knowledge base and now working with a Neurovascular Implant company as the regulatory landscape shifts to accommodate the MDSAP and the new EU MDR/IVDR.