Job Scope:
· Product Registration
o Manage the process of registration and regulatory approvals for new products, change notification of products and special authorisation route, ensuring all regulatory compliance, submission.
o Handle the maintenance and renewal of Product Registration License for Singapore and/or various countries, ensuring adherence to the country specific requirements.
o 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
o Conduct assessment on risk class, grouping of the products and marketing history for new products.
o 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.
o Keep abreast of the new regulatory requirements both in Singapore and/or other countries in the region.
· Quality Management
o 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.
o Responsible for Quality system documentation and quality approval process including maintenance of accurate and complete records and files.
o Conduct half-yearly GDMPDS/Quality training for existing staff, new staff and whenever there are new updates.
o 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.
o Communicate and train Operations and Sales on the SOPs and quality standards.
o Collaborate across functionally with various Business Units and external authorities or stakeholders for contribution to the completion of regulatory submissions and reporting.
o 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.
o Maintain compliance to GDPMDS (SS620) standard & requirements.
· Audit & Others
o Participate in Quality System Audits by internal and external auditors.
o Conduct post audit management review on the audit results and the necessary follow up actions
o Handle the yearly GDPMDS (SS620) audit for Asia and Singapore
o Participate and handle quality system audits by supplier/manufacturers as and when required.
o Handle all related licensing & permits eg IMDA, NEA, intercompany agreements and related business licensing
o 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
