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QA/RA Specialist - Malaysia, Indonesia & Brunei

Location: Kuala Lumpur, Malaysia
Position Type: Unfixed Term
Job Function: Regulatory Affairs

Responsibilities 

 

Quality Management Representative

Ensuring implementation and overall compliance of the Group Quality Management System (QMS) processes and products, especially the following  –

  1. Corporate policies and procedures
  2. Applicable quality standards
  3. 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
  1. Carry out TTOR quality analysis.

 

Regulatory Affairs

  • 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

 

Requirements

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.

 

 

 

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