Regulatory & Quality Specialist (ISO13485 & FDA MedTech)

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

About Us

For over five decades, Computime Group Limited has been at the forefront of engineering and manufacturing, recognized globally for quality, reliability, and innovation. ComtecNova, the Singapore‑based innovation hub of Computime Group, provides a powerful gateway to accelerate our market expansion into the Medical Technology (MedTech) & Health Technology (HealthTech) sector.

Job Summary

The Regulatory & Quality Specialist is accountable for driving and sustaining regulatory and quality compliance across multiple global manufacturing sites. This role serves as a global quality governance function, ensuring consistent implementation of the Quality Management System and continuous compliance with ISO 13485, FDA QSR (21 CFR Part 820), and applicable international medical device regulations.

Key Responsibilities

• Global Manufacturing Oversight: Act as the central QA/RA authority for internal manufacturing sites worldwide; drive & monitor compliance, identify risks, and drive timely remediation.
• QMS Governance: Maintain and govern the global ISO 13485‑compliant QMS, ensuring consistent interpretation and application across regions.
• Audit & Inspection Readiness: Lead internal audits; support FDA inspections and ISO certification audits; ensure effective closure and verification of CAPAs and nonconformances.
• Regulatory Compliance: Ensure ongoing compliance with FDA QSR, MDR, Corrections & Removals, and applicable global regulatory requirements; support regulatory submissions and lifecycle maintenance.
• Risk & Quality Performance: Conduct risk‑based assessments, trend quality metrics, and elevate systemic compliance issues with defined mitigation plans.
• Manufacturing & Product Quality: Review and approve manufacturing quality records, change controls, and validations; ensure risk management (ISO 14971) is applied across manufacturing and lifecycle changes.
• Cross‑Site Alignment: Drive global standardization while accommodating region‑specific regulatory requirements; partner with site and operations leadership to embed quality ownership.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Quality, or related field.
• 3–5+ years of experience in medical device Quality and/or Regulatory Affairs.
• Strong working knowledge of ISO 13485; FDA QSR (21 CFR Part 820); Manufacturing quality systems and audits.
• Demonstrated experience driving compliance within manufacturing environments.
• Strong documentation, communication, and stakeholder management skills.
• Willingness to travel to manufacturing sites when required.

Preferred Qualifications

• Experience supporting FDA inspections and ISO certification audits at manufacturing sites.
• Familiarity with EU MDR (2017/745) and Technical Documentation.
• Experience with electronic QMS (eQMS) systems.
• Certifications (RAC, CQA, CQE) preferred.

Key Competencies

• Global regulatory judgment and risk‑based decision making.
• Authority and confidence to challenge non‑compliance.
• Ability to drive alignment and accountability across regions.
• Strong executive‑level communication and escalation skills.

What We Offer

• Competitive salary and benefits.
• Opportunity to influence and strengthen manufacturing compliance.
• High‑impact role with cross‑site visibility.
• Continuous learning and professional development support.