Quality Assurance and Regulatory Engineer

7 days ago

Singapore SPACE (MEDTECH) PTE. LTD. Full time

**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.

**Requirements**:

- University degree in the field of Biomedical Engineering, Electrical and Electronic Engineering, Mechanical Engineering, or other relevant field
- Prior relevant experience will have an advantage.
- Organized, meticulous and detail oriented.
- Keen to learn, self-motivated, and able to work independently, good team player.
- Good verbal communication and technical writing skills.
- Able to start asap.

**Benefits**
- Monthly salary: S$2,000 - $4,800.
- Subsidised medical insurance, annual and sick leaves.
- Practical experience working on algorithms designed for patients and doctors.
- Opportunity to interact with other professionals including regulatory pathway experts.
- Opportunity for leading, managing, training, creativity and innovativeness.
- Flexible work arrangement.
- Fun and exciting working environment.

**Application Process

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