QRC Specialist

To support the business in SEA region in all aspects of quality and regulatory compliance.

Duties and responsibilities:

• Familiar with ISO 13485, ISO 9001, and GDPMDS
• Implement and maintain QMS & GDPMDS in Singapore, including coordinating annual inspection audit, and management review activities
• Support in QMS related activities, e.g. monthly review, audits, process reviews, and improvements, CAPA, complaints, etc
• Manage Adverse Event reporting according to local regulation and Global SOP
• Compile and prepare product registration packages and other relevant licenses applications, change notifications, renewals
• Ensure timely update of product registration details in databses in a compliant and timely manner
• Source documents and guidelines, consolidate file and maintain product technical information
• Keep close tract of changes in country regulatory requirements, and provide regulatory intelligence on the current and upcoming new regulations/ guidelines
• Perform all other duties assigned by the Company and/or Manager

Requirements:

• Diploma/ Degree in Biomedical/ Science/ Engineering or other relevant fields
• 1-2 years of relevant experience in QA/ RA, preferably in medical device industry
• Familiar with ISO 13485/ ISO 9001/ GDPMDS, and possess knowledge in Medical Device regulations
• Responsible, work independently, detail oriented
• Able to manage and prioritize multiple projects and tasks to meet deadlines