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
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