Quality Assurance, Regulatory Affairs Manager

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:

• BSc in Biotechnology, Biomedical Sciences, or equivalent.
• 10+ years of experience in quality assurance, regulatory affairs, and compliance in the biomedical or in-vitro diagnostics 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.

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:

• BSc in Biotechnology, Biomedical Sciences, or equivalent.
• 10+ years of experience in quality assurance, regulatory affairs, and compliance in the biomedical or in-vitro diagnostics 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.