[Hybrid] RA Specialist (Medical Devices)

Overview

A global medical device company has recently established its Japan subsidiary and is expanding its local quality organization. This role serves as the Quality Responsible Person (Hinseki) and supports the operation and maintenance of the company’s Marketing Authorization Holder (MAH) framework in Japan. The position works closely with both local teams and overseas manufacturing partners to ensure quality compliance, manage customer complaints, and support broader regulatory and post-market quality activities.

Key Responsibilities

Maintain and improve the Quality Management System (QMS) in compliance with Japanese regulatory requirements Manage customer complaints and coordinate investigations with global manufacturing partners Review, analyze, and evaluate quality information and recommend appropriate actions (CAPA, improvements) Communicate with regulatory authorities and manufacturing partners regarding quality matters Support regulatory affairs and post-market surveillance activities Collaborate cross-functionally to resolve quality-related issues Requirements Required Experience 3+ years of QA experience in the medical device industry in Japan Experience serving as, or supporting, a Quality Responsible Person (Hinseki) within an MAH structure Knowledge of the PMD Act and related quality regulations (QMS, GVP, etc.)

Bachelor’s degree in science, engineering, or related field Native-level Japanese communication skills; business-level English preferred Preferred Experience Experience with active medical devices Knowledge of laser devices or regulated electrical equipment Familiarity with Electrical Safety Law and Radio Act Work Environment Tokyo Flexible work style including remote work and flexible office environment International team with collaboration across global manufacturing sites Benefits Compensation & Benefits Competitive salary package (details shared confidentially) Full-time position with standard benefits Why This Role Exposure to global stakeholders and international manufacturing teams Work within an open and flexible office culture supporting collaboration and innovation