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Job description Quality Assurance and Regulatory Affairs Specialist (1-year contract) Getinge South East Asia Pte Ltd.
- Compile and prepare product registration packages and other relevant licenses application
- Manage product registration, change notifications, renewals, adverse event and FSCA reporting
- Source documents and guidelines, consolidate file and maintain product technical information
- Keep close track of changes in country regulatory requirements, and provide regulatory intelligence on the current and upcoming new regulation/ guideline
- Support in QMS related activities, e.g., monthly review, audits, process reviews and improvements, CAPA, complaints, etc
- Ongoing administrative support and other ad-hoc tasks as assigned by QRC Manager
- Diploma/ Degree in Science/ Engineering or other relevant fields
- Knowledge in Medical Device regulations, experience in regulatory affairs or QA / quality management systems, preferably related to medical devices, will be advantageous
- Strong administrative skills
- Responsible, work independently, detail oriented, keen to learn
- Able to manage and prioritize multiple projects and tasks
- All are welcome to apply
- Remote work options
- Medical coverage