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.
Working on the labeling requirements led to an opportunity to lead the Technical publications group in Brea. 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. Reinforcement of EU regulations were acquired by being an auditor for TUV SUD. The journey to acquire regulatory knowledge continues with MicroVention and working on their neurovascular medical devices.