Senior QA/RA Specialist - Malaysia, Indonesia & Brunei
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Location: Kuala Lumpur, Malaysia
Position Type: Unfixed Term
Job Function: Regulatory Affairs
Quality Management Representative
- Ensuring implementation and overall compliance of the Group Quality Management System (QMS) processes and products for Malaysia, Indonesia & Brunei, especially the following –
- Corporate policies and procedures
- Applicable quality standards
- Local Laws and Regulation -
- Manage and maintain GDPMD licenses and other quality certifications as necessary
- Conduct internal and external audits as required.
- Maintain and update Establishment License Certifications as required.
- Ensure implementation of field actions, post-market surveillance and vigilance management based on local country regulations and requirements.
- Perform mandatory problem reporting (adverse event reporting) based on local regulatory guidelines
- Coordinate with local team for timely closure of field actions and field safety corrective actions.
- Carry out TTOR quality analysis.
5. Contributing to the coordination / implementation of the QMS in ASEAN region when necessary
- Responsible for following and implementing local / country regulatory requirements for Malaysia Indonesia and Brunei.
- Support for other registration activities within ASEAN when necessary. Support in organization of ASEAN QA/RA activities when necessary
- 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 in countries.
- 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.
- 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
- >4 years of regulatory affairs and/or quality assurance experience
- Preferred to have knowledge of GDPMD and ISO 9001:2015 requirements and IVD directive
- 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
- Able to coordinate and influence local teams in involvement in QMS
- Overall understanding of medical device industry and AMDD requirements.