Job Requirements
Job benefits
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Remote work options
Thanks to technology, we no longer have to be physically present at the office to be productive. Joining our company allows you to work anywhere without place-constraint.
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Medical insurance
To ensure your health and wellbeing, you have various medical plans to choose from depending on your situation and unique needs. From partial up to full medical coverage, we got you covered.
Skills
Job description for Quality Assurance and Regulatory Affairs Specialist (1-year contract) at 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