Principal Medical Device QMS & Regulatory Engineer

RN Care; Singapore; On-site; SGD 100,000 - 125,000; Full time

Job summary

A healthcare technology company in Singapore is looking for a professional to ensure compliance with quality management systems and provide support for medical technology projects. The ideal candidate will hold a relevant degree and possess experience in risk management and project coordination. This role involves tracking project milestones, conducting risk assessments, and ensuring compliance with ISO standards.

Qualifications

• Experience in quality management systems and risk management processes.
• Hands-on experience in medical technology development.
• Proven track record in implementing or maintaining QMS.

Responsibilities

• Implement and maintain ISO 13485 and IEC 62304-compliant QMS processes.
• Provide technical guidance to medical technology projects.
• Conduct clinical need filtering and de-risking activities.

Skills

Quality management systems

Risk management processes

Medical device design and development

Project coordination

Education

Bachelor’s or Master’s Degree in Engineering or Science

Job description

A healthcare technology company in Singapore is looking for a professional to ensure compliance with quality management systems and provide support for medical technology projects. The ideal candidate will hold a relevant degree and possess experience in risk management and project coordination. This role involves tracking project milestones, conducting risk assessments, and ensuring compliance with ISO standards.