Prepares robust regulatory applications to achieve departmental and organizational objectives.
Reviews of product and manufacturing changes for compliance with applicable regulations
Complies with Ministry of Health, Labour and Welfare (MHLW)/Pharmaceutical and Medical
Device Agency (PMDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of stakeholders.
May act as a regulatory representative on product development teams in local, communicates regulatory requirements and impact of regulations to the team.
May interface directly with Pharmaceutical and Medical Device Agency (PMDA) and other regulatory agencies.
Reviews protocols and reports to support regulatory submissions.
Prepares A1/A2/B1 reimbursement applications to Ministry of Health, Labour and Welfare
Act as regulatory team member providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
Reviews device labeling and advertising materials for compliance with Japan approval licenses and applicable regulations as needed.
Supports the product release process by updating approval information in Global Product
Registration (GPR) system.
Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor’s degree (BS, BA) in technical discipline preferred.
Background - Work Experience, Language Skills, Technical Knowledge
Ability to multi-tasks, prioritizes and meets deadlines in timely manner.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Extensive experience with medical device regulations and submissions in Japan preferred.
Experience working in a broader enterprise/cross division preferred.
Other Options
Ability to maintain regular and predictable attendance.
