Regulatory Compliance Group, Quality Assurance Senior Specialist

Publication date 2025/08/29

Work Location , Expected Annual Income :

Tokyo,10.0M ～ 12.0M

About the Company :

Global American Medical Device Manufacturer

Responsibilities :

Job Details: Quality systems, business license management, conformity certification, and foreign manufacturer registration management.

-Maintain and improve the effectiveness of the Quality Management System (QMS), promote a culture of quality and continuous improvement across the organization through business license management, audit response, and document control.

-Build and maintain trust with regulatory authorities and internal/external stakeholders to support the foundation for delivering safe and high-quality products to patients and customers.


Role & Responsibilities:
Primary Responsibilities:
1. Business License Management & Regulatory Compliance
・ Maintain licenses for medical devices and related products.
・ Submit QMS conformity investigation applications and maintain conformity certificates.
・ Obtain and renew Foreign Manufacturer Registration (FMR).
・ Lead external audit responses (coordination with auditors, overall audit management).

2. Quality Management System (QMS) Maintenance
・ Support the development of quality policies, objectives, and manuals.
・ Plan, execute, and support QMS initiatives.
・ Conduct and record management reviews.
・ Evaluate and respond to legal revisions.
・ Provide regular reports and statements to senior management.
・ Lead nonconformance management (NCEP, CAPA, QN, PIRe, PIR).
・ Maintain training and internal audit processes.
・ Maintain procedures for validation of QMS-related software.

3. Document & Record Management
・ Maintain procedures for quality documents and records; operate document management systems.
・ Review documents and collaborate with relevant departments (e.g., lead IRR, participate in CoP).

Benefits :

Employment Type: Full time employee
Office Location: Tokyo, Japan
Working Style: Hybrid
Interview Steps: 3
Budget Range: Up to 11mil annual total.
Reporting Language: Japanese

Required Experience / Abilities / Skills :

MUST HAVE:
-3+ years of QMS management experience at a medical device or life science manufacturer
-Understanding of Japan regulatory policy and reporting guidelines.
-Native ability in Japanese

Contact Information :

JAC International Healthcare Team
Dunstan Matthews
Email: d-matthews@jac-international.jp

If you are interested, email us for inquiry!

JOB ID : IJB2009784