Job Description

The incumbent will optimise a high level of expertise in coordinating responses to competent authority inquiries associated with medical device report submission, review and evaluation of adverse events to ensure its compliance with company policies and procedures.

• Subject Matter expert for medical device complaint handling responsibilities from follow-ups to case processing and assessments for several countries in Asia Pacific and/or North America region.
• Ensure the Customer complaint investigation, procedures, and activities comply with FDA Quality System Regulations, ISO, and Medical Device Directives for Vigilance.
• Initiate, track, follow-up and close Corrective and Preventive Actions.
• Monitor the Asia Pacific Regional Complaint Center Operational Metrics/Service Level Agreement performance to ensure operational level performance targets.
• Usage of Microsoft Excel with knowledge of formulas, statistical and modeling tools.
• Analyse information using problem-solving/root cause analysis.

Continuous and versatile learning opportunities given|Strong customer and stakeholder management in a regional exposure

• Study background: BSc Degree preferably in scientific, technical or engineering discipline
• Minimum 2 years of Quality Assurance/Customer Complaint Specialist experience
• Quality System standards and regulations ISO 9000:2008, ISO 13485: 2016 or US FDA QSR (21 CFR 803 & 820) will be an advantage.
• Have fluent oral and written communication skills in English
• Demonstrated ability to work independently, manage deadlines, and handle multiple tasks efficiently
• Proficiency in statistical analysis and metrics reporting and associated tools and packages

Our client is a leading international medical technology company that creates medical devices and laboratory equipment to improve the standards of medical discovery, diagnostics and patient care delivery.

• Promising opportunity to advance in an international company
• Regional exposure to customers in Asia Pacific and/or North America region
• Comprehensive remuneration package designed to enhance financial well-being and health

Michael Page