Found Description
Kickstart your career in biotechnology as a Quality Assurance and Regulatory Affairs Associate at BTNX Inc. in Pickering, Ontario. Focus on quality systems and medical device regulations while collaborating with top management.
BTNX Inc. is seeking an entry-level associate to monitor and uphold the Quality System in accordance with various regulations. In this role, you will develop in-depth knowledge of ISO13485:2016 and US FDA guidelines. Your responsibilities will entail maintaining regulatory compliance and supporting quality assurance processes.
Key Responsibilities:
• Update Senior Management on regulatory requirements
• Manage current facility and product registrations
• Assist in FDA and international documentation submissions
• Maintain and update the ISO 13485 Quality Management System
• Coordinate internal and external audits
Requirements:
• Bachelor’s or master’s degree in relevant field
• 0 to 2 years of relevant experience
• Strong organiz...
BTNX Inc. is seeking an entry-level associate to monitor and uphold the Quality System in accordance with various regulations. In this role, you will develop in-depth knowledge of ISO13485:2016 and US FDA guidelines. Your responsibilities will entail maintaining regulatory compliance and supporting quality assurance processes.
Key Responsibilities:
• Update Senior Management on regulatory requirements
• Manage current facility and product registrations
• Assist in FDA and international documentation submissions
• Maintain and update the ISO 13485 Quality Management System
• Coordinate internal and external audits
Requirements:
• Bachelor’s or master’s degree in relevant field
• 0 to 2 years of relevant experience
• Strong organiz...
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