Regulatory Affairs and Quality Assurance Manager

Labgistics Limited; Singapore; On-site; SGD 140,000 - 180,000; Full time

Job summary

Labgistics Limited in Singapore seeks a seasoned Quality Assurance & Regulatory Affairs Manager to lead quality and regulatory functions across Singapore operations. The role ensures compliance with international standards and maintains regulatory certifications while driving continuous improvement to support healthcare and life sciences innovation.

You will oversee the QMS, audits, licenses, and product registrations, including Medical Devices, Therapeutic Products, and Hazardous Substances.

Qualifications

• Degree in Science, Engineering, or 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.

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.

Skills

Quality Assurance

Regulatory Affairs

Lead Auditor

ISO 9001

ISO 13485

GDP/GDPMDS

GMP

Auditing

Hazardous Substances

Radioactive Materials

Project Management

People Leadership

Education

Bachelor's degree in Science/Engineering

Regulatory Affairs Certification

Job description

Join a leading life sciences group driving innovation inMicrobiology,Oncology, andInfectious Diseasesacross Southeast Asia.

As we expand the business, we are seeking a seasonedQuality Assurance & Regulatory Affairs (QRA) Managerto lead quality and regulatory functions across our Singapore operations. This role is critical in ensuring compliance with international standards, maintaining regulatory certifications, and fostering continuous improvement to support our mission of advancing healthcare and scientific innovation.

Key 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.

Qualifications & Requirements

• 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.