Prepare and submit regulatory dossiers for product registrations, change notifications, and renewals for designated SEAT countries based on ASEAN CSDT format. Monitor regulatory submission status and maintain accurate, up-to-date RA/QA records and databases.
Review product labelling and promotional materials to ensure compliance with local regulatory requirements.
Conduct regulatory intelligence and communicate local regulatory requirements and updates to relevant stakeholders.
Maintain and support the development of local and regional QMS in accordance with corporate procedures and local quality requirements (e.g., GDPMDS).
Plan and conduct internal audits to monitor compliance with processes, identify gaps, and support continuous improvement of the QMS.
Manage post-market surveillance activities, including complaint handling, adverse event reporting, and field safety corrective actions.
Lead and drive regional RA/QA initiatives across SEAT while supporting broader Asia MEA regional initiatives.
Manage designated regional RA/QA operational activities, including but not limited to complaint analysis, dashboard maintenance, gRASS, and regulatory alignment meetings for new product launches.
Your Talents
Recognised Diploma/Degree in Life Sciences, Engineering, Regulatory, or a related field.
3-5 years of experience in RA/QA within the Medical Device industry.
Good knowledge of EU MDR and ASEAN MDD, with familiarity in ISO 13485 and/or GDP standards.
Data analytics and data visualisation skills are a plus.
Experience working in a regional or multi-country environment with cross-functional teams.
Excellent organisational, analytical, and communication skills. Strong interpersonal and time management skills are highly essential.
