Specialist, Regulatory Affairs
Specialist, Regulatory Affairs
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Job Description
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:
Bachelors 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
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
MD Medical Devices
LOCATION:
Japan > Tokyo : Mita South Tower
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Unclear Seniority
Employment Type
Full-Time
