Quality and Regulatory Affairs Lead

1. Quality Assurance Supervisor

The Quality Assurance Supervisor in a Japanese medical‑device MAH is the legally responsible person who establishes and manages the QMS compliant with MHLW Ordinance No. 169, oversees product release, supplier control, and change management, and ensures continuous compliance with PMDA and prefectural requirements.

·      Implement and Maintain Quality System that meets the standards of MHLW Ordinance No. 169

·      Ensure compliance of manufacturer with Japanese QMS requirements

·      Documentation and Record keeping – Maintain accurate and traceable records for all QMS processes, in Japanese, for the legally required retention period.

·      Internal audit management – plan and execute internal quality audits

·      Japan supplier qualification - Assess and evaluate contracted organizations (e.g warehouse, testing labs)

·      Communication with authorities – support responses during PMDA and other authorities inspections

·      Recall management support – participate in decision and execution of recalls or corrections

·      Quality reporting to the General Marketing Supervisor

·      Monitor changes in Japanese QMS regulations, standards and PMDA guidelines, update internal procedure and train staff accordingly

2. Safety Management Supervisor

The Safety Management Supervisor ensures continuous monitoring of the safety of all medical devices after they are marketed in Japan and implements prompt corrective or preventive actions to protect patients and users.

·      Post Market Safety System Management: Establish and operate a vigilance system as required by GVP ordinance. Ensure procedures exist for collecting, evaluating and reporting safety information.

·      Collect information on malfunctions, adverse events, or complaints from users, distributors, or healthcare providers. Perform medical and technical evaluation of seriousness and causality.

·      Submit mandatory adverse event reports and periodic safety reports (PSR) within regulatory time frames defined by MHLW notifications and maintain traceability of all reports.

·      Promote vigilance awareness and train employees and distributors on safety reporting.

·      Partner with Headquarters Vigilance team for better operation as Domestic Safety role & responsibilities. Review safety data for trends, propose preventive measures, and ensure continuous improvement of the post‑market safety system.

3. Regulatory Affairs Lead

·      Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC devices to PMDA/ARCB

·      Preparation and maintenance of regulatory submissions and registrations of INSIGHTEC devices in APAC countries

·      Development of annual Post Market Survey (PMS) reports to PMDA, and develop a submission document for re-evaluation on applicable INSIGHTEC devices based on data reports by CRO

Information collection of an amendment of local premarket regulatory requirements

·       Interpretation of local regulator rules or rule changes and ensure that they are communicated through corporate policies and procedures

·      Work closely with various teams of Country manager reporting lines (CRO, Applications, CAM, Marketing) located at the INSIGHTEC Japan office

·      Perform other duties RA associated as required

·      Be Based in Japan

·      Fluent in Japanese and English languages

·      Meet the requirements on Safety Control Manager and QMS Manager

·      Apply business and Safety ethical standards

·      High integrity

·      Multitask and manage multiple projects to meet deadlines

·      Work with cross-functional teams (located in JP)

·      Ability to foster relationships with regulatory agencies, TMG consultants and colleagues

·      Strong documentation skills: ability to write, review, and prepare complex documents (English/JP)

·      Think analytically and critically

·      Proficient with Microsoft Office

·      Minimum Qualifications:

·      B.S. or B.A. degree in scientific, engineering, pharma, or medical field. Advanced degree preferred.

·      ≥3 years total in QA/RA/Vigilance for medical devices

·      Knowledge of PMD Act, Ordinance 169 (QMS), Japan vigilance/recall systems

·      Understanding of Japanese vigilance and recall systems, including reporting flows and timelines.

·      Awareness of labeling, import control, and product registration processes.

·      Experience in creating technical documentation (STED or equivalent)

·      Experience with Class II and Class III medical in Japan and preferably also in Taiwan, Korea, and other APAC countries

·      Knowledge/experience with QMS/ISO13485 is preferable

·      Other Requirements:

·      Ability to travel both domestically and internationally is required