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
Benefits
- Monthly salary: S$3,800 - $5,000.
- 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
- Email your resume to Human Resource at [email protected]
- Only shortlisted candidates will be notified for interview.
