• Regulatory Affairs cum Quality Assurance Specialist Singapore
  • Celecti Pte Ltd in Singapore, , Singapore
  • jobs
  • 1 week ago

jobs description

• work week: Mondays to Fridays
• accessible from MRT Station; Central Location
• salary and benefits

A US Based MNC in the distribution/ manufacturing of Medical Devices, is seeking for an experience and suitable candidate to join the growing team!

Job Responsibilities:
• and coordinate in the development of regulatory strategies based on the needs of the company for each product range and change
• regular review with the Sales and Marketing and other relevant stakeholders to ensure strategies are align to company’s needs and marketing strategies
• and work closely with all relevant internal and external parties to understand and evaluate the requirements for product registrations for the assigned market
• the preparation of submissions for new products, amendment/ variation of approved products and submissions that support the maintenance of existing licenses
• and update registration activities and/ or status to all relevant stakeholders on a regular basis
• timely approval of... registration in target market
• changes to licenses due to product/ manufacturing related changes to minimize/ prevent risk and impact to the business
• license expiry and establish routine follow up with the affected countries to ensure license renewal be conducted in a timely manner
• on time reporting on any adverse events to authorities; review complaints for potential adverse events and submit reports to appropriate agencies
• quality system/ GDP procedures and support on-site audit for Malaysia establishment
• and maintenance of commercial Quality Management System and certification according to the Company’s QA and country regulatory requirements
• in both internal and external Quality System Audit e.g. GDPMS certification
• as the management representative for Singapore and Malaysia to oversee compliance of business operations as per company GDP and GDPMDS guidelines and requirements
• QA Management in preparation of materials and follow up actions for Management Reviews and meetings
• for document control, change control and training management
• and ensure activities required for maintenance of QMS are performed, including risk management, supplier management and qualification management
• post market surveillance activities e.g. product complain, recall, AE reporting, vigilance reporting, FSCA execution and closure
• the Corrective and Preventive Action (CAPA) system and monitor to ensure timely closely
• function collaboration to create and upload SOPs/ Work instructions
• product relabeling/ packaging required as per country’s labeling requirements

Job Requirements
• Diploma/Bachelor's degree or equivalent in relevant field
• 3 years of regulatory experience in medical device industry for SEA+ region
• who have obtained a Regulatory Certification are a plus
• prior experience working for a medical device manufacturer establishing and maintenance of commercial Quality Management System and certification SS620/GDPMDS/ISO13485 internal auditor certified will be advantageous

Interested and suitable candidates, please email your CV in MS Word to

[email protected]

Ammerline Lam Sze Yi

CEI Reg. No.: R1104463

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