Quality Assurance and Regulatory Affairs Manager

7 days ago

Pasir Panjang, Singapore Private Advertiser Full time

We are a leading life sciences organization operating across Southeast Asia, supporting advancements in healthcare, diagnostics, and laboratory technologies. As we continue to grow regionally, we are seeking an experienced Quality Assurance & Regulatory Affairs Manager to lead and oversee quality and regulatory functions across our Singapore and regional entities. This role is pivotal in ensuring compliance with international standards, maintaining regulatory certifications, and driving continuous improvement to support our mission of elevating healthcare and scientific innovation.

Key Responsibilities:

  • Define and execute quality and regulatory strategies, performance metrics, and targets for Singapore and regional entities.
  • Lead, supervise, and train the QA/RA team in areas such as 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 operations.
  • Maintain the Quality Management System (QMS) and all related certifications (GDP, GDPMDS, ISO 9001, ISO
  • Oversee QMS documentation and records to ensure compliance with relevant standards and regulations.
  • Lead internal and external audits (customers, regulatory authorities) and ensure timely closure of findings.
  • Manage and resolve quality issues—including investigation, 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 completion of action items.
  • Set, monitor, and report on quality objectives and performance indicators.
  • Drive continuous improvement initiatives to enhance quality processes, systems, and controls.
  • Identify training needs and coordinate quality and compliance training across the organization.
  • 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 and report variances as needed.
  • Provide timely QRA performance updates to Management.

Qualifications and Requirements:

  • Degree in a related Science or Engineering discipline, or equivalent experience.
  • Minimum 5 years' experience in a medical device, pharmaceutical, or lifescience industry, specifically in Quality and Regulatory functions.
  • Minimum 5 years 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 is 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; prior experience handling hazardous or radioactive substances is an advantage.
  • Strong analytical skills with high attention to detail.
  • Excellent communication and interpersonal skills, with the ability to work collaboratively and influence cross-functional teams.
  • Highly motivated, results-oriented, and proactive in driving continuous improvement.

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