Specialist, Regulatory Affairs

Primary Function

This position performs specialized level work assignments and / or preparation, and submission of

documentation for the product regulatory registration, ensuring products and procedures comply with

regulatory agency specifications. Supports necessary regulatory activities required for product market

entry.

Major Responsibilities

General :

Prepares robust regulatory applications to achieve departmental and organizational objectives.

Reviews of product and manufacturing changes for compliance with applicable regulations

Change Control).

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

MHLW).

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.

Functional Area :

Product regulatory registration in Japan

Maintenance of the approval licenses

Procut Reimbursement Application (A1 / A2 / B1)

Minimum Requirements

Education :

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.