Regulatory & Quality Specialist (ISO13485 & FDA MedTech)

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

About Us

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. We are seeking a Regulatory & Quality Specialist to drive, enforce, monitor, and sustain compliance with ISO 13485, FDA Quality System Regulations (21 CFR Part 820), and other applicable global medical device regulations.

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.

The position requires strong authority, sound regulatory judgment, and the ability to influence site leadership without direct reporting responsibility, maintaining all manufacturing locations in a constant state of inspection readiness.

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 escalate 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.
• Willing 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