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 catteng@spacemedtech.com • Only shortlisted candidates will be notified for interview.