Job Description

JOB DESCRIPTIONS: * Ensure products manufactured or distributed comply with the required regulations/standards. * Develop, register, facilitate and maintain all regulatory submissions related to the establishment and product registration with t JOB DESCRIPTIONS: Ensure products manufactured or distributed comply with the required regulations/standards. Develop, register, facilitate and maintain all regulatory submissions related to the establishment and product registration with the applicable Regulatory Authority. Liaising with regulatory authorities, designated agents, and notified bodies on all regulatory-related matters. Provide regulatory support to product development and marketed product. Keep up to date with changes in regulatory, statutory, and Quality Management System requirements. Ensure company compliance with required regulatory, statutory, and Quality Management System requirements. Review and update regulatory and Quality Management System documentation. Review labeling, storage, and packaging requirements in accordance with regulatory requirements to ensure compliance in product labeling. Participates in post-market surveillance activities by conducting routine systematic literature reviews. Handle quality- and regulatory-related matters with Customers and Suppliers (including contract manufacturers). Manage Supplier's quality and follow up on Supplier Corrective Action Report (SCAR). Manage QC Inspection activities and coordinate with Suppliers on QC inspection activities. Manage customer returns and complaint process. Conduct Quality Audits and drive continuous improvement efforts, through facilitating and collaborating with cross-functional and inter-department stakeholders. Provide training in matters related to regulatory and Quality Management System. JOB REQUIREMENTS: Bachelor's Degree in Science or equivalent. Minimum 3 years of experience in medical device regulatory positions or similar roles and responsibilities is preferred. Knowledge of ISO 13485 and GDPMD. Knowledge in product testing, licensing, registration, and certification. Knowledge of Corrective Action and Preventive Action (CAPA) processes and Root Cause Analysis (RCA). This position will be hiring under Hartalega subsidiary company which is Mun Global.