RA / QA Specialist

작업 내용

My Client is a global provider of medical technologies.Key Responsibilities

• Liaise with the necessary parties, country RA, registration agents, distributors, sales marketing and other relevant stakeholders, to understand and evaluate the requirements for product registrations for designated market
• Ensure on time reporting of adverse events to authority Reviews complaints for potential adverse events and that reports of adverse events are submitted to appropriate agencies in accordance with established procedure and domestic and international regulations and standards
• Maintain quality system/GDP procedures and support on site audits when required

Key Relationships/ Interfaces

• Senior Regulatory Affairs Manager
• QARA group, International
• QARA group, US
• External notified bodies and authorities

Key Requirements

• Min 2 3 years regulatory experience working in a medical company doing business in SEA
• Individuals who have obtained a Regulatory Certification are a plus
• Previous experience working for a medical device manufacturer