Bachelor's degree in a scientific or engineering discipline (e.g., Biomedical Engineering, Life Sciences), or equivalent practical experience.
5 years of experience in regulatory strategy within the Healthcare and Lifesciences specifically the medical device industry, with a focus on SaMD.
Ability to communicate in Japanese and English fluently to support client relationship management in this region.
Preferred qualifications:
Experience in successful submissions and approvals for SaMD products with the PMDA and MHLW.
Knowledge of Japanese medical device regulations, including those specific to SaMD.
Understanding of relevant Asia-Pacific regulations.
Excellent organizational, verbal and written communication skills to effectively communicate complex regulatory information to both technical and non-technical audiences.