QMS & Regulatory Leader (ISO 13485, MDR, 21 CFR)

Maternal Newborn Health Innovations; Singapore; On-site; SGD 80,000 - 120,000; Full time

Job summary

A healthcare organization based in Singapore is seeking a QMS and Regulatory Manager. This role will oversee quality management systems and ensure compliance with global regulations. Responsibilities include preparing regulatory submissions, managing complaints, and driving QMS training programs. Candidates should have a Bachelor’s degree and 8-10 years of experience in the medical device industry with fluency in English and Mandarin. Competitive salary and benefits offered.

Qualifications

• Minimum 8–10 years of experience in quality and regulatory roles in the medical device industry.
• Strong knowledge and hands-on experience with ISO 13485, EU MDR and 21 CFR Part 820.
• Proven ability to manage regulatory compliance activities in dynamic environments.

Responsibilities

• Oversee the QMS and ensure compliance with ISO 13485 and FDA regulations.
• Lead the preparation and submission of regulatory dossiers.
• Manage complaint evaluations and ensure timely reporting to regulatory authorities.

Skills

Regulatory compliance knowledge

Analytical skills

Communication skills

Leadership skills

Fluent in English and Mandarin

Education

Bachelor’s degree in science, engineering, or regulatory-related discipline

Job description

A healthcare organization based in Singapore is seeking a QMS and Regulatory Manager. This role will oversee quality management systems and ensure compliance with global regulations. Responsibilities include preparing regulatory submissions, managing complaints, and driving QMS training programs. Candidates should have a Bachelor’s degree and 8-10 years of experience in the medical device industry with fluency in English and Mandarin. Competitive salary and benefits offered.