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

Requirements:

• 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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