QRA Manager

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

This role is posted on behalf of the Wholesale Trade Company with support from the Singapore Business Federation (SBF) under the JSIT WST initiative. SBF/JSIT facilitates outreach and connections only and does not act as an employment agency. All hiring decisions are made solely by the hiring company.

Our member company is seeking a meticulous and motivated ORA Manager to join the team In this role, you will play a critical part in leading Quality and Regulatory Affairs across Singapore and regional operations, ensuring regulatory compliance, effective quality management systems and continuous improvement.

Job Responsibilities

• Develop and implement quality and regulatory strategies, performance metrics, and targets for Singapore and regional operations.
• Lead, mentor, and manage the QA/RA team across document control, audit management, and product registration.
• Oversee all quality and regulatory licenses, certifications, and product registrations, including Medical Devices, Therapeutic Products, Radioactive Products, Hazardous Substances, and Controlled Drugs.
• Manage Quality and Regulatory projects across Singapore and regional entities.
• Maintain and enhance the Quality Management System (QMS) and ensure compliance with certifications (GDP, GDPMDS, ISO 9001, ISO 13485).
• Supervise QMS documentation and records to ensure adherence to relevant standards and regulations.
• Lead internal and external audits and ensure timely closure of findings.
• Investigate and resolve quality issues, including root cause analysis, corrective actions, and documentation.
• Handle regulatory matters related to the sales and distribution of regulated products.
• Conduct annual Management Reviews and ensure timely completion of action items.
• Monitor, track, and report on quality objectives and performance indicators.
• Drive continuous improvement initiatives to strengthen quality processes, systems, and controls.
• Identify training needs and coordinate quality and compliance training programs.
• Act as the primary liaison with regulatory authorities and customers on QRA matters, including regulatory updates.
• Oversee pharmacovigilance activities and related training to ensure compliance.
• Develop and manage the QRA annual budget, reporting variances as needed.
• Provide timely updates on QRA performance to Management.

Job Requirement

• Degree in Science, Engineering, or a related discipline, or equivalent experience.
• Minimum 8 years’ experience in Quality and Regulatory functions within the medical device, pharmaceutical, or life sciences industry.
• Minimum 5 years’ experience in a supervisory or 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; experience leading audits is highly advantageous.
• Familiarity with quality management methodologies (e.g., Six Sigma, Lean, Root Cause Analysis) is a plus.
• Knowledge of regulatory processes for Form A Poison License, Controlled Drug License, Therapeutic Products and Medical Device Registration, Hazardous Substances, and Radioactive Products. Experience handling hazardous or radioactive substances is an advantage.