Quality Assurance/Regulatory Affairs Manager - Bukit Batok

Basic Functions:

• Manage a total quality assurance program to ensure quality of products.
• Responsible for implementation and maintenance of the Quality Management System (QMS) in the Company.
• Co-ordinate timely worldwide product registration, maintenance of licenses and regulatory affairs.

Duties:

• Ensure Quality Management System (QMS) and Quality Control procedures are properly implemented and maintained at all levels.
• Provide direction and decision on quality-related matters and ensure products meet specified and regulatory requirements.
• Ensure that proper document control procedure is implemented for product specifications, operation manuals and all quality-related documents.
• Ensure product and process design control/validation activities are carried out and documented to demonstrate process capability and quality compliance.
• Review and ensure that all internal and / or external corrective actions on quality issues are effectively implemented and verified.
• Conduct quality systems review to ensure that the system is suitable, effective and that it satisfies the required standards.
• Compilation and review of performance data and bench testing of MP Bio products in support of US FDA registration, CE marking activities required under the IVD Directives/IVD Regulations and other worldwide product registration requirements. This includes review of the Design History File, Design Dossier and Technical file.
• Ensure that Worldwide product registration documents are properly documented, compiled and timely in accordance with worldwide regulatory requirements.
• Identify responsibilities and authorities of subordinates and their training needs.
• Set annual goals and objectives for the department.
• Review and approve Certificate of Analysis and Certificates of Origin.

Requirements:

• Ability to: Establish quality assurance system, controls and undertake product registration.
• Knowledge of: Various quality control/process control requirements, quality management system including ISO standards, U.S. Quality System Requirements, Canadian, Australian, Brazilian, Taiwanese and Korean Quality Management Systems, Good Manufacturing Practice, MDSAP (Medical device Single Audit Program) and documentation relating to in-vitro diagnostic and/or biomedical products
• Education: BSc in Biotechnology or Biomedical Sciences or equivalent.
• Experience: At least 10 years of relevant working experiences.