Global Regulatory & Quality Lead – MedTech Compliance

COMTECNOVA PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

An innovative MedTech firm in Singapore is seeking a Regulatory & Quality Specialist responsible for ensuring compliance with ISO 13485 and FDA regulations across global manufacturing sites. This role entails governance of the Quality Management System and oversight of audits and inspections while requiring strong communication and risk-based decision-making skills. Candidates should hold a relevant bachelor's degree and have 3-5 years of experience in medical device quality or regulatory affairs. Competitive salary and benefits offered.

Benefits

Competitive salary and benefits

Opportunity for professional development

Cross-site visibility in a high-impact role

Qualifications

• 3-5+ years of experience in medical device Quality and/or Regulatory Affairs.
• Strong knowledge of manufacturing quality systems and audits.
• Experience driving compliance within manufacturing environments.

Responsibilities

• Act as the central QA/RA authority for internal manufacturing sites worldwide.
• Maintain and govern the global ISO 13485-compliant QMS.
• Lead internal audits and support FDA inspections.

Skills

ISO 13485

FDA QSR (21 CFR Part 820)

Documentation skills

Stakeholder management

Education

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

Job description

An innovative MedTech firm in Singapore is seeking a Regulatory & Quality Specialist responsible for ensuring compliance with ISO 13485 and FDA regulations across global manufacturing sites. This role entails governance of the Quality Management System and oversight of audits and inspections while requiring strong communication and risk-based decision-making skills. Candidates should hold a relevant bachelor's degree and have 3-5 years of experience in medical device quality or regulatory affairs. Competitive salary and benefits offered.