Regulatory Affairs and Quality Assurance Executive - EASMED ASIA PTE. LTD.

Roles & Responsibilities

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

3. Audit & Others

Requirements

We regret to inform that only shortlisted candidates will be contacted.

Tell employers what skills you have

Licensing

Regulatory Compliance

Quality Management

Quality System

Approval Process

Regulatory Affairs

Traceability

Compliance

Audit Management

Medical Devices

Audits

Regulatory Requirements

Regulatory Submissions

Audit