Responsibilities
1. 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.
2. 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.
3. 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
We regret to inform that only shortlisted candidates will be contacted.
