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