Head of Regulatory Affairs

The Company is seeking a Head of Regulatory Affairs to oversee and lead all regulatory operations for medical devices and related products in the Japanese market. The successful candidate will be responsible for the planning and execution of regulatory strategies, as well as for the integration of Japanese regulatory requirements into global development programs. This role involves direct liaison and negotiation with regulatory authorities, including PMDA/MHLW, and requires a deep understanding of approval applications, lifecycle management, and compliance for medical devices. The Head of Regulatory Affairs will also be tasked with managing and organizing the regulatory affairs team, and will have the opportunity to work in a global environment, directly reporting to the US headquarters. Applicants must have a minimum of 10 years' experience in regulatory affairs for medical devices and combination products, with a focus on PMDA application and approval acquisition for Class II-IV devices. A Bachelor's degree in a science or engineering field is required, along with fluency in Japanese and business-level English. The ideal candidate will have a pharmacist license and experience as a General Manager of Manufacturing and Sales. The role offers significant autonomy in promoting regulatory strategy and approval acquisition, and the company values a candidate who can bring their regulatory approval experience to the forefront of the position.