We are desiring to recruit a diligent QA / RA OFFICER to join our collaborative team at Mediplas Respiratory Products Sdn Bhd in Kuala Lumpur.
Growing your career as a Full time QA / RA OFFICER is an outstanding opportunity to develop indispensable skills.
If you are strong in attention to detail, leadership and have the right attitude for the job, then apply for the position of QA / RA OFFICER at Mediplas Respiratory Products Sdn Bhd today!
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
Benefits of working as a QA / RA OFFICER in Kuala Lumpur:
● Company offers great benefits
● Continuous Learning Opportunities
● Leading Industry Pay