QA Specialist

MAIN RESPONSIBILITIES:

Regulatory Affairs

• Handle all Registration requirement of Medical Device with the Medical Device Authority (MDA)

• Liaison with appointed Comformity Assessment Body (CAB) in planning for product verification

• Liaise with local and global Regulatory Affairs personnel to ensure compliance with product registration

• On a timely basis, prepare or arrange for preparation, the Regulatory budgets, reports and forecasts

• Deliver monthly report for all regulatory activities and status report on registration to Top Management

• Provide regulatory support to all relevant Abbott Diagnostic's department in order to achieve commercial plan goal within Malaysia

• Provide timely information regarding Malaysia's legislation to management to ensure continuous Regulatory compliance

Quality Assurance

• Ensure compliance to Malaysia's Quality System as per stated in the ADD Divisional procedures and Good Distribution Practise Medical Device

• To Act as Quality Representative and facilitate both Internal and External Audits

• To carry out Post Market Survelliance and Mandatory Problem Reporting timely as per local and global requirments

• Facilitate closure of CAPA with functional owners for observation by internal and or external auditors

• Manage all local distributors as per divisional documents;Commercial Affiliate - Warehousing Storage and Distribution Processes

• Manage all Abbott Diagnoctics Purchasing and Supplier Control Processes as per stated in the divisional procedures

• Deployment of Training of Division Procedure to relevant employees to ensure guidelines are followed.

• To work functional heads, and draw up Training Plan for respective employees, and ensure timely completion of training

• Key user for SBM tools for both CAPA and Distributor Control

  Maintenance of Site Master File/Regulatory Compliance manual

EDUCATION/ EXPERIENCE:

• Degree in Biomedicl Sciences/Bachelor in Science/Medical Laboratory Technology/Pharmacy
• Demonstrate strong attention to details and communication skills (writing/verbal) in English
• Demostrate ability to work in a multidisciplinary environment and adapt to a variety of projects/business needs
• Good Documentation Practice