Global QA/RA Lead – MedTech (ISO13485 & FDA QSR)

COMTECNOVA PTE. LTD.; Singapore; On-site; SGD 60,000 - 85,000; Full time

Job summary

A health technology firm in Singapore is seeking a Regulatory & Quality Specialist responsible for ensuring regulatory compliance and the quality management system across global manufacturing sites. The ideal candidate should possess a Bachelor's degree in Engineering or Life Sciences, with 3-5 years of experience in medical device quality and regulatory affairs. Strong knowledge of ISO 13485 and FDA regulations is essential. This role offers competitive salary and opportunities for professional growth.

Benefits

Competitive salary and benefits

Opportunity for professional development

High-impact role with cross-site visibility

Qualifications

• 3-5+ years of experience in medical device Quality and/or Regulatory Affairs.
• Demonstrated experience driving compliance within manufacturing environments.
• Willingness to travel to manufacturing sites when required.

Responsibilities

• Drive and monitor compliance across global manufacturing sites.
• Maintain and govern the global ISO 13485-compliant QMS.
• Lead internal audits; support FDA inspections and ISO certification audits.
• Ensure ongoing compliance with FDA QSR, MDR, and global regulations.
• Conduct risk-based assessments and monitor quality metrics.

Skills

Strong working knowledge of ISO 13485

Regulatory Affairs expertise

Documentation skills

Communication skills

Stakeholder management

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Job description

A health technology firm in Singapore is seeking a Regulatory & Quality Specialist responsible for ensuring regulatory compliance and the quality management system across global manufacturing sites. The ideal candidate should possess a Bachelor's degree in Engineering or Life Sciences, with 3-5 years of experience in medical device quality and regulatory affairs. Strong knowledge of ISO 13485 and FDA regulations is essential. This role offers competitive salary and opportunities for professional growth.