QA/RA Manager — Medical Devices & Regulatory Lead

JSIT for WST (Wholesale Trade) by Singapore Business Federation (SBF); Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

Wholesale Trade Company seeks an ORA Manager to lead Quality and Regulatory Affairs across Singapore and regional operations. You will drive regulatory compliance, maintain QMS, and oversee audits, registrations, and pharmacovigilance training.

You will manage budgets, liaison with authorities and customers, and steer continuous improvement initiatives within a robust quality culture.

Qualifications

• Degree in Science, Engineering, or related discipline.
• 8+ years of Quality and Regulatory experience in medical devices, pharma, or life sciences.
• Minimum 5 years in a supervisory/management role.
• Strong knowledge of ISO 9001:2015, ISO 13485:2016, GDP/GDPMDS, and GMP requirements.
• Lead Auditor certification in ISO 9001 and/or ISO 13485 preferred; audit leadership advantageous.
• Familiarity with Six Sigma, Lean, and Root Cause Analysis.
• Knowledge of regulatory processes for Form A Poison, Controlled Drug, Therapeutic Products and Medical Device Registration, Hazardous Substances, and Radioactive Products.

Responsibilities

• Develop and implement quality and regulatory strategies for Singapore and regional ops.
• Lead, mentor, and manage the QA/RA team across document control, audits, and product registrations.
• Oversee licenses, certifications, and registrations for Medical Devices, Therapeutic Products, and Hazardous Substances.
• Manage QMS documentation and records to ensure standards alignment.
• Lead internal and external audits and close findings timely.
• Investigate and resolve quality issues with root-cause analyses and corrective actions.
• Coordinate regulatory matters for sales and distribution of regulated products.
• Conduct annual Management Reviews and track action items.
• Monitor quality objectives and performance indicators; drive improvements.

Skills

Quality management

Regulatory affairs

Auditing

Process improvement

Education

Degree in Science/Engineering or related discipline

Tools

Lead Auditor certification (ISO 9001/ISO 13485)

Job description

Wholesale Trade Company seeks an ORA Manager to lead Quality and Regulatory Affairs across Singapore and regional operations. You will drive regulatory compliance, maintain QMS, and oversee audits, registrations, and pharmacovigilance training.

You will manage budgets, liaison with authorities and customers, and steer continuous improvement initiatives within a robust quality culture.