Opportunity Description
Main Job Scope
- Manage Quality Management System to be compliant with relevant Standards (e.g. ISO13485).
- Determine requirements and regulatory pathway for product registration with regulatory authorities (e.g., FDA, CE Mark, NMPA, HSA, regulatory authorities in other countries).
- Create and manage documentations relevant to regulatory clearance.
- Work with product design team to ensure technical documentations are compliant with regulatory requirements.
- Manage the conduct of internal and external audits, and the necessary tests needed for regulatory clearance.
- University degree in the field of Biomedical Engineering, Electrical and Electronic Engineering, Mechanical Engineering, or other relevant field(s)
- Prior relevant experience will have an advantage. Especially with active devices.
- Organized and meticulous.
- Keen to learn, self‑motivated, and able to work i...
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