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Senior 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 for Malaysia, Indonesia & Brunei, 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 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.
  1. Carry out TTOR quality analysis.

5. Contributing to the coordination / implementation of the QMS in  ASEAN region when necessary

 

Regulatory Affairs

  • 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

Skills

  • 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.

 

 

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