Job Description
Join our established medical device company as a Product Complaint and Vigilance Associate and play a crucial role in ensuring patient safety and regulatory compliance across the Asian market. This is an exciting opportunity for a detail-oriented professional passionate about quality systems and risk management in the healthcare sector.
In this role, you will be responsible for managing product complaints, conducting investigations, and implementing corrective and preventive actions. You will work closely with cross-functional teams to ensure compliance with international regulations, including ISO 13485, FDA requirements, and other regional standards. Your expertise will contribute to our commitment to delivering safe and effective medical devices to patients across Asia.
We offer a collaborative work environment, professional development opportunities, and the chance to make a real impact on patient outcomes. If you have a strong background in quality management, excellent analytical skills, and a dedication to excellence in medical device safety, we encourage you to apply for this position in Kuala Lumpur.
Responsibilities
- Manage and document product complaints in accordance with company procedures and regulatory requirements
- Conduct thorough investigations to identify root causes of product issues and implement corrective actions
- Maintain vigilance systems to monitor product performance and identify potential safety concerns
- Collaborate with R&D, manufacturing, and quality teams to address product issues and improve designs
- Prepare regulatory reports and submissions for health authorities in Asian markets
- Analyze complaint trends and provide recommendations for product improvements and quality enhancements
- Stay updated on evolving regulations and standards in medical device safety across Asian countries
Qualifications
- Bachelor's degree in Life Sciences, Engineering, or related field
- Minimum 2-3 years of experience in quality assurance, regulatory affairs, or product complaint management
- Familiarity with ISO 13485, FDA QSR, and other medical device regulations
- Strong analytical and problem-solving skills with attention to detail
- Excellent written and verbal communication skills in English
- Experience working with quality management systems and complaint handling software
- Knowledge of medical device vigilance processes and reporting requirements