Quality Assurance and Regulatory Affairs Manager

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.