Batam Quality Regulatory Executives

Responsibilities: Ensures deep understanding of medical device standards and Regulations especially ISO 13485, and the European Medical Device standard (MDR), FDA requirements and other national regulatory frameworks Ensures all Batam staff are aware of quality principles and regulatory requirements

Support the implementation and compliance of the Unique Device Identification (UDI) System Manages document of External Origin in Batam supporting Perth site regulatory Prepare risk management reports, including risk assessments, analysis, and mitigation plans, in compliance with regulatory requirements and relevant standards like ISO 14971 as supporting for Regulatory Perth site

Prepare, Drafted, and work closely with Perth side on the Risk Management Procedure and classifications based on Regulations Prepare the necessary regulatory documents for medical devices, including PMA applications, Technical Files, and CE certification documents for Europe, ensuring compliance with regulatory requirements Prepare and Drafted PMS (Post Market Surveillance) reports preparation based on collected post-market data and adverse event reports, ensuring timely and accurate submissions to regulatory authorities

Coordinate with Perth site Regulatory Manager and other teams to gather data and support regulatory submissions and compliance activities