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(s)
Prior relevant experience will have an advantage. Especially with active devices.
Organized and meticulous.
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
Apply through this portal, or email your resume to Human Resource at [Confidential Information]
Only shortlisted candidates will be notified for interview.
