Senior Regulatory Affairs Specialist

Job Overview

This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Senior Regulatory Affairs Specialist is expected to drive best practices in office and administrative management within the organisation to maximise efficiency and growth. The main responsibility is to proactively support the organisation in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.

Responsibilities

Senior Regulatory Affairs Specialist

• Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and its route of submission.
• Preparing and submitting applications related to Initial, Renewal, Change Notification of medical device submissions, including follow up until approval.
• Promptly inform manufacturer is...