To Support the business in South East Asia region in all aspects of quality and regulatory compliance.
Duties & 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
- Coordinate and execute Field Safety Coorective Action (FSCA) per 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 databases 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
