Specialist, Regulatory Affairs

JOB DESCRIPTION:

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.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

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MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: