Quality Assurance and Regulatory Engineer

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(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 [email protected]
• Only shortlisted candidates will be notified for interview.