Senior RA QA Executive M F D

Your Mission

• 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.
  
  

• 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.
  
  

• Leave Benefits (Vacation Leave, Sick Leave, Parental Leave, etc.)
• Birthday Benefits
• Transport Allowance (if applicable to role)
• Accessibility to Public Transport
• Flexible Work Arrangements
• Group Health Insurances
• Flexi-Benefit Reimbursement
• Wellness Programs and Activities
• Professional Development Opportunities
• Global Exposure & Business Travel Opportunities (if applicable to role)
• All other statutory benefits