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Urgent! Quality Assurance, Regulatory Affairs Manager Job Opening In Singapore Highway Strip Pioneer – Now Hiring Private Advertiser

Quality Assurance, Regulatory Affairs Manager



Job description

Basic Functions:

  • Oversee the quality assurance program to ensure product quality and compliance.

  • Implement and maintain the Quality Management System (QMS).

  • Manage worldwide product registration, licensing, and regulatory compliance.

Key Responsibilities:

  • Ensure proper implementation and maintenance of QMS and Quality Control procedures.

  • Provide direction on quality matters, ensuring compliance with regulatory requirements.

  • Maintain document control for product specifications, manuals, and quality records.

  • Oversee product and process validation to demonstrate compliance and capability.

  • Ensure effective implementation of corrective actions for quality issues.

  • Conduct quality system reviews to maintain compliance with required standards.

  • Manage regulatory documentation for worldwide product registration, including US FDA, CE marking, and IVD regulations.

  • Identify training needs, set department objectives, and oversee staff responsibilities.

  • Approve Certificates of Analysis and Certificates of Origin.

Requirements:

  • Bachelor's degree in Biotechnology, Biology, Biomedical Sciences, or a related scientific discipline, or an equivalent qualification.

  • Preferably 5 years of experience in Quality Assurance, Regulatory Affairs, and Compliance within the biomedical, in-vitro diagnostics, medical devices or related industry.

  • Strong expertise in QMS, ISO standards, GMP, MDSAP, and global regulatory frameworks.

  • Proficiency in regulatory documentation and compliance processes.

  • Strong analytical skills with the ability to collaborate across teams and regulatory bodies.


Required Skill Profession

Other General



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    Unlock Your Quality Assurance Potential: Insight & Career Growth Guide


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