Senior Regulatory Affairs Specialist

Position 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 regulatory, office and administrative management within the organization to maximize efficiency and growth. The main responsibility is to proactively support the organization in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.

Essential Job Functions

Regulatory

• 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 documents related to Initial, Renewal, Variations/Change Notification of medical devices, follow-up until approval process.
• Promptly inform...