Quality Management Representative
Ensuring implementation and overall compliance of the Group Quality Management System (QMS) processes and products, especially the following –
- Corporate policies and procedures
- Applicable quality standards
- Local Laws and Regulation -
- Manage and maintain GDPMD licenses and other quality certification as necessary
- Conduct internal and external audits as required.
- Ensure implementation of field actions and post-market surveillance and vigilance management based on local country regulations and requirements.
- Perform mandatory problem reporting based on local regulatory guidelines
- Coordinate with team for timely closure of field actions and field safety corrective actions
- Carry out TTOR quality analysis.
- Responsible for following and implementing local / country regulatory requirements for Malaysia and Indonesia.
- Ensure collaboration with subsidiary and distributors to specify the regulatory requirements and schedule of product registrations, changes and renewals.
- Manage product registration, change notifications and renewals, ensuring timely submissions.
- Responsible for obtaining the regulatory clearances and ensuring regular follow-up and updates
- Keeping up to date with regulatory watch process, updates on regulations and informing stakeholders on the key impact.
- Closely monitor the validity of licenses and registrations and carry out renewal in time.
- Conduct change impact assessment based on local guidelines when required
- Support for other registration activities within ASEAN when necessary
- Support in organization of ASEAN QA/RA activities when necessary
Skills / Education Requirements
- Bachelor degree or country equivalent is expected
- Prefers 2 – 3 years of quality assurance and regulatory affairs experience
- Knowledge of GDPMD requirements and IVD directive, ISO an advantage, preferred.
- Experience in directly managing quality audits, preferred.
- Full knowledge of regulatory requirement in Malaysia
- Fluent English and Bahasa Malaysia to communicate with key stakeholders
- Good communication skills and ability to work in a team
- Overall understanding of medical device industry and AMDD requirements.