QA / RA OFFICER

Responsibilities :-

Quality Management System

• Responsible for writing/revised procedures and processes to support development of QMS. Integrate EU MDR and MDA requirements into ISO 13485
• Update and maintain GDPMD requirements
• Ensure all manufacturing processes and procedures meet the quality standard and regulation requirements
• Monitor and maintain the company document control system
• Preparation internal audit activities, involvement in Internal/External audit, act as internal auditor as nominated by company
• Any other tasks assigned from time to time

Regulatory Affairs

• To ensure all licenses are valid including Company's Establishment license, Notified Body certificate and product license
• Coordinate with suppliers and/or contract manufacturers to gather necessary technical information and documentation required for building the product's technical file
• Carry out application related to the Product Registration and Re-registration with the Conformity Assessment Body (CAB) and Medical Device Authority (MDA) on behalf of Company by preparing necessary documents such as Common Submission Dossier Template (CSDT)
• Creating and Maintenance of Product Technical File update which is compliance with Local and MDR requirements

Qualification and Experience:-

• Candidate must possess at least STPM/Certificate/Diploma in any discipline
• At least 3 year(s) of working experience in regulatory affair or quality management system relating to medical device
• Familiar with ISO 13485 and GDPMD Quality System
• Familiar with MDA, EU MDR, International Regulations and Standards
• Knowledge in Medical Device for Class B (MDA) and Class IIa (MDR) submission
• Good interpersonal and communication skills
• A good command of spoken and written English and Bahasa Malaysia
• High attention to detail and ability to follow instructions
• Able to work under pressure and with minimal supervision
• Preferably available to commence work immediately