Job description
About the role
Establishing, monitoring and maintaining the quality system implementations in accordance with the ISO 13485:2016, MDA Malaysia, US-FDA QSR, European MDR and related International Medical Device Regulations.
What you’ll be doing
- Responsible to assist in monitoring and tracking of company quality objectives.
- Responsible to manage quality document control system in accordance with the ISO 13485:2016 quality management system, US-FDA QSR, European MDR and related International Medical Device Regulations.
- Responsible to co-ordinate internal audit and conduct process audit in accordance with ISO 13485 quality management system, US-FDA QSR, EU European MDR and related International Medical Device Regulations.
- Responsible to coordinate for in-house preparation prior to external audit by certification body or customers.
- Responsible to manage the entire process of product registration of current and new products with various regulatory bodies.
- Provide regulatory affairs and technical support by working together with marketing, e Research and development, Engineering team on establishing the path of regulatory compliance for new / existing products.
- Prepare training plan for cGMP and GDP training of all employees of the company as well as supervision of the compliance of the standards.
- Responsible to ensure the corrective action replies of all internal and external audits discrepancies was closed effectively.
- Coordinates Change Control process (Document change, design change, production and process change) to ensure appropriate changes and actions are implemented.
- Responsible for the management of Customer Complaint, Corrective Action and Preventive Action (CAPA) investigation as well as Nonconformances (NC) investigation and process activities.
- Maintain Risk Management File and coordinate Risk Analysis with other functions & ensure Risk Analysis has been developed, evaluated and reviewed.
- Corresponded with regulatory authorities regarding planning of registrations, time frames and in case of enquiries.
- Perform any other pertinent responsibility that may be assigned occasionally as required by Top Management or immediate superior.
What we’re looking for
- Minimum six years of professional experience in regulatory affairs or in quality management system relating to medical devices.
- A minimum of six years experience in Medical Device based GMP manufacturing operations.
- Experience working in a GMP, ISO 13485:2016 and related International Medical Device Regulations.
- Experience in the establishment and development of Greenfield sites is an advantage.