Regulatory Affairs Specialist

Job Overview

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

• 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 (when required).
• Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Liaising with external parties on matters relating to medical device regulatory requirements.
• Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
• Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.

• At least a Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology,
• Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent. Graduated as

• At least 2 years’ experience in the medical device industry and especially in regulatory affairs.

• Good management skills
• Fluent English with excellent writing and verbal communication skills
• Result oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities.
• Computer literate with advanced skills in Microsoft Office (Word, Power Point, etc..)
• At ease in working in a small structure, start-up-type, where tasks and responsibilities are in constant move.
• Able to operate in a multicultural environment.
• High level of autonomy at work, yet with profound team-spirit