Regulatory Affairs & QA, S$4K, 12-month, Toa Payoh

Location Singapore
Discipline Manufacturing & Production
Job Reference BBBH137955_1714701096
Salary S$3500 - S$4000 per month
Consultant Name Fu Yee Chen, Lyn
Consultant Email
Consultant Contact No. 62325738
EA License No. 02C3423
Consultant Registration No. R1110796

Job Scope:

  • Product Registration
    • Manage the process of registration and regulatory approvals for new products, change notification of products and special authorisation route, ensuring all regulatory compliance, submission.
    • Handle the maintenance and renewal of Product Registration License for Singapore and/or various countries, ensuring adherence to the country specific requirements.
    • Maintain the records in the system on Letter of Authorisation (LOA) for sales issued by manufacturers, providing the BU Manager a platform to track and take necessary action
    • Conduct assessment on risk class, grouping of the products and marketing history for new products.
    • Conduct assessment when there are changes to the existing products, communicating the changes to the authorities (HSA), and document/communicate the approval internally to Operations and Sales.
    • Keep abreast of the new regulatory requirements both in Singapore and/or other countries in the region.
  • Quality Management
    • Serve as quality management representative for the company and liaison contact with authorities (HSA) on quality issues as necessary, which include reporting adverse events/product complaint/FSCA to the local authorities.
    • Responsible for Quality system documentation and quality approval process including maintenance of accurate and complete records and files.
    • Conduct half-yearly GDMPDS/Quality training for existing staff, new staff and whenever there are new updates.
    • Develop, revise and review SOPs, Quality Forms and Records when necessary to ensure up-to-date and good standards are maintained, as well as in compliance with the regulatory requirements.
    • Communicate and train Operations and Sales on the SOPs and quality standards.
    • Collaborate across functionally with various Business Units and external authorities or stakeholders for contribution to the completion of regulatory submissions and reporting.
    • Serve as main point of contact for the manufacturers for product compliance process such as product recalls, safety corrections, product complaints; and co-ordinate with Operations to conduct the traceability of sales, customers etc.
    • Maintain compliance to GDPMDS (SS620) standard & requirements.
  • Audit & Others
    • Participate in Quality System Audits by internal and external auditors.
    • Conduct post audit management review on the audit results and the necessary follow up actions
    • Handle the yearly GDPMDS (SS620) audit for Asia and Singapore
    • Participate and handle quality system audits by supplier/manufacturers as and when required.
    • Handle all related licensing & permits eg IMDA, NEA, intercompany agreements and related business licensing
    • Execute ad-hoc relevant projects


  • Degree, preferably in Science discipline
  • Relevant background and knowledge in quality management system/regulatory affair and requirements relating to medical devices

Additional Information:

  • Start Date: Immediate
  • Working days and Hours: Monday to Friday, 9am to 6pm
  • Contract Duration: 12-month
  • Location: Toa Payoh

Lyn, Yee Chen Fu EA License No. 02C3423 Personnel Registration No. R1110796

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