Regulatory Affairs and Quality Assurance Executive - Hiring Urgently

Responsibilities

1. Product Registration

(a) Manage the process of registration and regulatory approvals for new products, change notification of products and special authorisation route, ensuring all regulatory compliance, submission.

(b) Handle the maintenance and renewal of Product Registration License for Singapore and/or various countries, ensuring adherence to the country specific requirements.

(c) 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

(d) Conduct assessment on risk class, grouping of the products and marketing history for new products.

(e) 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.

(f) Keep abreast of the new regulatory requirements both in Singapore and/or other countries in the region.

2. Quality Management

(a) 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.

(b) Responsible for Quality system documentation and quality approval process including maintenance of accurate and complete records and files.

(c) Conduct half-yearly GDMPDS/Quality training for existing staff, new staff and whenever there are new updates.

(d) 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.

(e) Communicate and train Operations and Sales on the SOPs and quality standards.

(f) Collaborate across functionally with various Business Units and external authorities or stakeholders for contribution to the completion of regulatory submissions and reporting.

(g) 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.

(h) Maintain compliance to GDPMDS (SS620) standard & requirements.

3. Audit & Others

(a) Participate in Quality System Audits by internal and external auditors.

(b) Conduct post audit management review on the audit results and the necessary follow up actions

(c) Handle the yearly GDPMDS (SS620) audit for Asia and Singapore

(d) Participate and handle quality system audits by supplier/manufacturers as and when required.

(e) Handle all related licensing & permits eg IMDA, NEA, intercompany agreements and related business licensing

(f) Execute ad-hoc relevant projects

Requirements

(a) Degree, preferably in Science discipline

(b) 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.