Responsibilities - 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 there’s any feedback from Authority to ensure successful product registration.
Communicating with customers in respond to their regulatory concerns.
Maintain regulatory database for the Company.
Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to Marketing Manager.
Assist sales team in discussion with client on regulatory related matters...