Quality Assurance and Regulatory Engineer

SPACE (MEDTECH) PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading MedTech company in Singapore is seeking a Quality Management Specialist to manage compliance with various regulatory standards. In this role, you will oversee the quality management system, ensure documentation meets requirements, and assist in regulatory product registrations. Ideal candidates will have a degree in engineering and strong communication skills. Benefits include a competitive salary and a flexible work environment.

Benefits

Monthly salary: S$2,000 - $4,800

Subsidised medical insurance

Flexible work arrangement

Qualifications

• University degree in Biomedical, Electrical, or Mechanical Engineering.
• Prior relevant experience preferred.
• Ability to work independently and in a team.

Responsibilities

• Manage Quality Management System compliance.
• Determine requirements for product registration.
• Create and manage documentation for regulatory clearance.

Skills

Organized

Detail-oriented

Good verbal communication

Technical writing

Self-motivated

Education

University degree in Biomedical Engineering or equivalent

Job description

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.
• Able to start asap.

Benefits

• Monthly salary: S$2,000 - $4,800.
• 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 [e-mail]
• Only shortlisted candidates will be notified for interview.